Feasibility Study of the TruSculpt Radiofrequency Device
Phase: NA
Conditions: Tissue Tightening
Sponsor: Cutera Inc.

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 1 of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
 
 
 
TI TL E P A G E 
 
 
 
 
Pr ot oc ol N u m b er:  
C -1 6 -T S 1 2  
Pr ot oc ol Titl e:  
F e asi bilit y  St u d y of t h e Tr u Sc ul pt R a di ofr e q u e ncy D e vic e  
S p o ns or:  
 
C ut er a, I nc . 
3 2 4 0 B a ys h or e B o ul e v ar d  
Bris b a n e, C A 9 4 0 0 5  
T el e p h o n e: 1 -4 1 5 -6 5 7 -5 5 3 8  
F ax:  1 -4 1 5 -7 1 5 -3 7 2 2  
C o nt act:  E mil y H u  a n d M att h e w H a m m o n d  
E m ail:  eh u @c ut er a.c o m , m h a m m o n d @c ut er a.c o m   
 
 
V ersi o n, D at e:  
V ersi o n 2 .0 , D at e d J a n u ar y 0 5, 2 0 17  
 
 
 
 
 
 
 
 
St at e m e nt of C o m pli a nc e  
T h e st u dy will b e c o n d uct e d i n acc or d a nc e wit h t h e d esi g n a n d s p ecific pr ovisi o ns of t his I R B a p pr ov e d pr ot oc ol, i n 
acc or d a nc e wit h t h e et hic al pri nci pl es t h at h av e t h eir ori gi n i n t h e D ecl ar ati o n of H elsi n ki, a n d t h at ar e c o nsist e nt 
wit h G o o d Cli nic al Pr actic e ( G C P) a n d t h e a p plic a bl e r e g ul at or y r e q uir e m e nt(s).  
 
 
 
 
 
N O T E:   T h e c o nfi d e nti al i nf or m ati o n i n t h e f oll o wi n g d oc u m e nt is pr o vi d e d t o y o u as a n I n v esti g at or, p ot e nti al I n v esti g at or, or 
c o ns ult a nt f or r evi e w b y y o u, y o ur st aff, a n d a p plic a bl e I nstit uti o n al R evi e w B o ar d. B y acc e pti n g t his d oc u m e nt, y o u a gr e e t h at 
t h e i nf or m ati o n c o nt ai n e d h er ei n will n ot b e discl os e d t o ot h ers, wit h o ut writt e n a ut h oriz ati o n fr o m C ut er a, I nc. exc e pt t o t h e 
ext e nt n ec ess ar y t o o bt ai n i nf or m e d c o ns e nt fr o m t h os e p ers o ns t o w h o m t h e d evic e will b e a d mi nist er e d. 
 
 
 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 2 of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
 
Pr ot oc ol Si g n at ur e P a g e – Pri nci p al I n v esti g at or  
 
 
P R O T O C OL C- 1 6- T S 1 2  
 
 
St u d y Titl e:   F e asi bilit y St u d y of t h e Tr u Sc ul pt R a di ofr e q u e nc y D e vic e  
 
 
Pr ot oc ol V ersi o n 2 . 0, D at e d J a n u ar y 0 5, 2 0 1 7 
 
I h av e r ec ei v e d a n d r e a d t h e pr ot oc ol d at e d J a n u ar y 0 5 , 2 0 1 7 a n d a gr e e t o a d h er e t o t h e r e q uir e m e nts. I 
a m a w ar e t h at my a d h er e nc e t o t h e a b o v e pr ot oc ol is m a n d at or y a n d t h at a ny c h a n g es i n t h e pr ot oc ol or 
i nf or m e d c o ns e nt f or m m ust first b e a p pr o v e d by C ut er a, I nc. a n d t h e I nstit uti o n al R e vi e w B o ar d, exc e pt 
t h os e c h a n g es n ec ess ar y t o eli mi n at e a p p ar e nt i m m e di at e h az ar ds t o s u bj ects.  I will pr o vi d e c o pi es of t his 
pr ot oc ol a n d all p erti n e nt i nf or m ati o n t o t h e st u d y p ers o n n el u n d er my s u p er visi o n. I will disc uss t his 
m at eri al wit h t h e m a n d e ns ur e t h ey ar e f ull y i nf or m e d r e g ar di n g t h eir r ol e i n t h e st u d y. I will e ns ur e t h at 
t h e st u d y is c o n d uct e d i n c o m pli a nc e wit h t h e pr ot oc ol, G o o d Cli nic al Pr actic e ( G C P), a n d all a p plic a bl e 
r e g ul at or y r e q uir e m e nts, a n d wit h t h e r e vi e wi n g I nstit uti o n al R e vi e w B o ar d (I R B) r e q uir e m e nts. I a gr e e t o 
c o m m e nc e t his st u d y o nly aft er d oc u m e nt e d I R B a p pr ov al is o bt ai n e d.  
 
 
 
 
Pri nci p al 
I nv esti g at or 
 
 
 
 
 
 
Si g n at ur e  
 
D at e  
 
 
 
 
 
 
 
 
 
Pri nt e d N a m e  
 
 
 
 
 
 
 
 
 
 
 
 
T a bl e of C o nt e nts 
Pr ot oc ol S u m m ar y ..........................................................................................................................................5  

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 3 of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
1  
P U R P O S E ................................................................................................................................................6  
2   
B A C K G R O U N D I N F O R M A TIO N  ...............................................................................................................6  
3 
S T U D Y O BJ E C TI V E S ................................................................................................................................. 7 
4  
S T U D Y D E SI G N ........................................................................................................................................7  
4. 1. 1  
Effic ac y E n d p oi nts  .................................................................................................................... 7 
4. 1. 2   
S af et y E n d p oi nt ........................................................................................................................ 7 
4. 2  
St u d y D ur ati o n ................................................................................................................................. 7 
4. 3 
St u d y Ass ess m e nts ..........................................................................................................................8  
4. 3. 1  
Eff ecti v e n ess Ass ess m e nt  ........................................................................................................ 8 
4. 3 . 2  
S af et y Ass ess m e nts .................................................................................................................. 9 
4. 4  
P h ot o gr a p hs ....................................................................................................................................9  
4. 5 
St u d y Disc o nti n u ati o n .....................................................................................................................9  
4. 6 
I n v esti g at or S el ecti o n ......................................................................................................................9  
5  
S T U D Y P O P UL ATI O N  ...............................................................................................................................9  
5. 1  
St u d y S u bj ect R ecr uit m e nt a n d S el ecti o n  .......................................................................................9  
5. 1. 1  
I ncl usi o n Crit eri a  ...................................................................................................................... 9 
5. 1 . 2  
Excl usi o n Crit eri a .................................................................................................................... 1 0 
5. 2  
S u bj ect N u m b eri n g ........................................................................................................................1 0  
5. 3 
S u bj ect Disc o nti n u ati o n Crit eri a ....................................................................................................1 1  
6  
S T U D Y P R O C E D U R E S ............................................................................................................................1 1  
6. 1 
M e as ur e m e nt T o ol … … … … … … … … … … … …... ................................................................................... 1 1 
6. 2 
Scr e e ni n g a n d E nr oll m e nt Visit Pr oc e d ur es ..................................................................................1 1  
6. 3 
4- w e e k a n d 1 2- w e e k F oll o w- U p Visits ..........................................................................................1 3  
7  
A D V E R S E D E VI C E E F F E C T S  ....................................................................................................................1 3  
7. 1 
D efi niti o ns .....................................................................................................................................1 3  
7. 1. 1  
A d v ers e D e vic e Eff ect ( A D E)  .................................................................................................. 1 3 
7. 1 . 2  
S eri o us A d v ers e D e vic e Eff ect ( S A D E) .................................................................................... 1 3 
7. 1 . 3  
A ntici p at e d S eri o us A d v ers e D e vic e Eff ect ( A S A D E) .............................................................. 1 3 
7. 1 . 4  
U n a ntici p at e d S eri o us A d v ers e D e vic e Eff ect ( U S A D E/ U A D E) .............................................. 1 5 
7. 2  
R ec or di n g A d v ers e D e vic e Eff ects .................................................................................................1 5  
7. 3 
F oll o w- u p of S u bj ects aft er A D Es ..................................................................................................1 5  
8   
P O T E N TI AL RI S K S / B E N E FI T S ...............................................................................................................1 5  
8. 1 
P ot e nti al Ris ks ...............................................................................................................................1 5  
8. 2 
P ot e nti al B e n efits ..........................................................................................................................1 7  

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 4 of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
8. 3 
Ris k M a n a g e m e nt ..........................................................................................................................1 7  
9  
D A T A A N AL Y SI S PL A N ...........................................................................................................................1 7  
9. 1 
S a m p l e Siz e ....................................................................................................................................1 7  
9. 2 
A n al ysis S ets ..................................................................................................................................1 7  
9. 3 
A n al ysis of Effic ac y E n d p oi nts .......................................................................................................1 7  
9. 3. 1  
Pri m ar y E n d p oi nt A n al ysis  ..................................................................................................... 1 7 
 
 
9. 4  
S af et y A n al ys es ..............................................................................................................................1 8  
1 0  
S U BJ E C T P A Y M E N T ...............................................................................................................................1 8  
1 1  
S T U D Y M A N A G E M E N T A N D A D MI NI S T R A TI V E P R O C E D U R E S .............................................................1 8  
1 1. 1 
Tr ai ni n g a n d M o nit ori n g ................................................................................................................1 8  
1 1. 2 I nf or m e d C o ns e nt ..........................................................................................................................1 8  
1 1. 3 
Pr ot oc ol C o m pli a nc e .....................................................................................................................1 9  
1 1. 3. 1 Pr ot oc ol A m e n d m e nts ...................................................................................................................1 9  
1 1. 3. 2 Pr ot oc ol D e vi ati o ns .......................................................................................................................1 9  
1 1. 4 
St u d y P ers o n n el .............................................................................................................................1 9  
1 1. 5 
Discl os ur e of Fi n a nci al I nt er est .....................................................................................................1 9  
1 1. 6 
D at a C oll ecti o n, R ec or d K e e pi n g a n d St or a g e ...............................................................................1 9  
1 1. 7 
S u bj ect C o nfi d e nti alit y ..................................................................................................................2 0  
1 1. 8 
P u blic ati o n P olicy ..........................................................................................................................2 1  
R E F E R E N C E S .................................................................................................................................................2 2  
 
 
 
 
 
 
 
 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 5 of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
Pr ot oc ol S u m m ar y 
 
Titl e  
F e asi bilit y  St u d y of t h e Tr u Sc ul pt R a di ofr e q u e ncy D e vic e  
O bj ecti v e  
 
T o e v al u at e t h e s af et y a n d effic acy  of t h e C ut er a tr u Sc ul pt 
r a di ofr e q u e ncy d e vic e f or o pti m al d eli v er y of t h er m al e n er g y 
t o t h e s ki n. 
St u d y D esi g n  
A si n gl e -c e nt er, pr os p ecti v e,  o p e n -l a b el st u d y 
E nr oll m e nt  
 U p t o 4 0 s u bj ects  
Pri m ar y E n d p oi nt  
 D e gr e e of i m pr o v e m e nt i n  t h e tr e at m e nt ar e a at 1 2 w e e ks 
p ost -tr e at m e nt as ass ess e d b y t h e I n v esti g at or . 
S af et y E n d p oi nt  
I nci d e nc e a n d s e v erit y of a d v ers e d e vic e eff ects d uri n g t h e 
st u d y p eri o d  
  
S u bj ect P o p ul ati o n  
F e m al e a n d m al e s u bj ects, a g e 1 8  t o 7 0  y e ars, Fitz p atric k s ki n 
t y p e I-VI  
Pl a n n e d Sc h e d ul e  
First s u bj ect e nr oll e d:  J a n u ar y 2 0 1 7  
L ast s u bj ect l ast visit:  J a n u ar y 2 0 1 8  
 
 
 
 
 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 6 of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
1  
P U R P O S E 
T h e p ur p os e of t his i n v esti g ati o n is t o e v al u at e t h e s af et y a n d effic acy o f t h e tr u Sc ul pt r a di ofr e q u e ncy ( R F) 
d e vic e f or o pti m al d eli v er y of t h er m al e n er g y t o t h e s ki n .  
2  
 B A C K G R O U N D I N F O R M A TI O N 
U n w a nt e d exc ess f at p oc k ets/ b ul g es h a v e b e e n a m o n g t h e t o p c o nc er ns ex pr ess e d b y p ati e nts i n t h e 
a est h etic fi el d. Alt h o u g h s ur gic al i nt er v e nti o ns pr o d uc e t h e m ost d efi niti v e r es ults wit h b o d y c o nt o uri n g, 
t h es e i n v asi v e m et h o ds r e q uir e si g nific a nt r ec o v er y ti m e a n d c o m e wit h i n h er e nt ris ks.   
 
As a n o n-i n v asi v e o pti o n, l as er, i nt e ns e p uls e d li g ht (I PL), R F, or a c o m bi n ati o n of t h es e t ec h n ol o gi es h a v e 
b e e n d e v el o p e d t o r e d uc e s ki n l axit y or f at wit h mi ni m al r ec o v er y ti m e a n d ris ks [ 1]. T h e ti g ht e ni n g eff ect 
of t h e t h er m al e n er g y g e n er at e d b y t h es e d e vic es h as b e e n us e d f or r e d ucti o n i n l axit y a n d f at i n ar e as 
i ncl u di n g b ut n ot li mit e d t o t h e f ac e, ar ms, a b d o m e n, t hi g h, b ac k a n d fl a n ks [ 2- 1 4].  
 
 
 
 
 
 
   
 
  
 
  
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 7 of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
 
  
 
 
 
3  
S T U D Y O BJ E C TI V E S 
T h e o bj ecti v es of t his st u d y ar e t o e v al u at e effic acy a n d s af et y of tr e at m e nt wit h t h e C ut er a tr u Sc ul pt R F 
d e vic e f or o pti m al d eli v er y of t h er m al e n er g y t o t h e s ki n. 
4  
S T U D Y D E SI G N 
T his is a si n gl e-c e nt er, pr os p ecti v e, o p e n-l a b el st u d y i n u p t o 4 0 s u bj ects, a g e 1 8  t o 7 0  y e ars, w h o d esir e 
R F tr e at m e nt f or tiss u e ti g ht e ni n g a n d/ or c ell ulit e r e d ucti o n . S u bj ects will r ec ei v e 1 R F tr e at m e nt a n d will 
b e f oll o w e d at 8 w e e ks a n d 1 2 w e e ks p ost-tr e at m e nt. 
 
4. 1       St u d y E n d p oi nts  
4. 1. 1  
Effic ac y E n d p oi nts 
4. 1. 1. 1  Pri m ar y Effic ac y E n d p oi nt 
 D e gr e e of i m pr o v e m e nt i n t h e tr e at e d ar e a at 1 2 w e e ks p ost-tr e at m e nt as ass ess e d b y t h e 
I n v esti g at or. 
4. 1. 2  S af et y E n d p oi nt  
 I nci d e nc e a n d s e v erit y of a d v ers e d e vic e eff ects d uri n g t h e st u d y p eri o d
 
 
4. 2  
St u d y D ur ati o n 
S u bj ects e nr oll e d i n t his tri al will b e as k e d t o p artici p at e f or a p pr oxi m at el y 4 m o nt hs a n d will c o m pl et e 4 
visits:  1 scr e e ni n g visit, 1 R F  tr e at m e nt visit, a n d 2 f oll o w- u p visits at 8  w e e ks ( ± 2 w e e ks) a n d 1 2 w e e ks 
( ± 2 w e e ks) p ost-tr e at m e nt.  

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 8 of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
4. 3  
St u d y Ass ess m e nts 
4. 3. 1  
Eff ecti v e n ess Ass ess m e nt 
4. 3. 1. 1  I n v esti g at or Gl o b al Ass ess m e nt of I m pr o v e m e nt 
T h e i n v esti g at or will b e as k e d t o r at e t h e d e gr e e of i m pr o v e m e nt of t h e tr e at e d ar e a at 1 2 w e e ks p ost-
tr e at m e nt as c o m p ar e d t o t h e s u bj ect’s b as eli n e p h ot os  usi n g t h e Gl o b al Ass ess m e nt of I m pr o v e m e nt 
Sc al e: 
 
  
  
 
4 = V er y Si g nific a nt I m pr o v e m e nt ( > 7 5 %) 
  
  
  
3 = Si g nific a nt I m pr o v e m e nt ( 5 1 –  7 5 %) 
  
  
  
2 = M o d er at e I m pr o v e m e nt ( 2 6 –  5 0 %) 
  
  
  
1 = Mil d I m pr o v e m e nt ( 5 –  2 5 %) 
  
  
  
0 = N o C h a n g e ( < 5 %) 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 9 of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
4. 3. 2  
S af et y Ass ess m e nts 
4. 3. 2. 1  I nci d e nc e a n d S e v erit y of A d v ers e E v e nts:   
F oll o wi n g t h e first R F tr e at m e nt, a d v ers e d e vic e eff ects ( A D Es) will b e ass ess e d p ost-tr e at m e nt a n d at 
e ac h s u bs e q u e nt s u bj ect visit usi n g t h e f oll o wi n g sc al e: 
 
1 = mil d: r e q uir es mi ni m al or n o tr e at m e nt a n d d o es n ot i nt erf er e wit h t h e S u bj ect’s d ail y  acti viti es. 
2 = m o d er at e: m a y c a us e s o m e i nt erf er e nc e wit h f u ncti o ni n g.  
3 = s e v er e: i nt err u pts S u bj ect’s us u al d ail y acti vit y a n d m a y r e q uir e tr e at m e nt. 
4. 4  
P h ot o gr a p hs 
St a n d ar diz e d di git al p h ot o gr a p hs will b e t a k e n of e ac h s u bj ect’s tr e at m e nt ar e a. P h ot o gr a p hs will b e t a k e n 
pri or t o a n d p ost all R F  tr e at m e nts, a n d at e ac h f oll o w- u p visit. 
 
 
 
 
  
4. 5  
St u d y Disc o nti n u ati o n 
T h e st u d y s p o ns or h as t h e ri g ht t o t er mi n at e t his st u d y at a ny ti m e.  R e as o ns f or t er mi n ati n g t h e st u d y 
m ay i ncl u d e, b ut ar e n ot li mit e d t o, u ns atisf act or y s u bj ect e nr oll m e nt or t h e i nci d e nc e or s e v erit y of 
a d v ers e e v e nts i n t his st u d y, or ot h er st u di es wit h t h e st u d y d e vic e, i n dic at es a p ot e nti al h e alt h h az ar d t o 
s u bj ects. 
4. 6  
I n v esti g at or S el ecti o n 
I n v esti g at ors will b e i n vit e d t o p artici p at e i n t h e st u d y b as e d o n t h eir m e dic al s p eci alt y, ex p eri e nc e 
c o n d ucti n g cli nic al r es e arc h st u di es a n d ex p eri e nc e i n t h e us e of e n er g y b as e d d e vic es f or a est h etic 
i n dic ati o ns. T h e sit e’s acc ess t o p ot e nti al st u d y s u bj ects a n d a bilit y t o c o o p er at e wit h st u d y r e q uir em e nts 
will als o b e c o nsi d er e d.  
5  
S T U D Y P O P UL ATI O N  
5. 1  
St u d y S u bj ect R ecr uit m e nt a n d S el ecti o n  
U p t o 4 0 m al e or f e m al e s u bj ects, a g es 1 8  t o 7 0 , wit h Fitz p atric k S ki n T y p e I- VI w h o d esir e R F tr e at m e nt 
will b e st u di e d. S u bj ects will b e r ecr uit e d t o p artici p at e fr o m t h os e p ati e nts w h o pr es e nt t h e ms el v es t o 
t h e sit e r e q u esti n g tr e at m e nt, or fr o m t h os e p ati e nts w h o r es p o n d t o a d v ertis e m e nt. O nl y s u bj ects w h o 
m e et all I ncl usi o n a n d Excl usi o n Crit eri a a n d pr ovi d e writt e n i nf or m e d c o ns e nt will b e e nr oll e d i nt o t h e 
st u d y.  
 
E ac h s u bj ect will b e e v al u at e d b y t h e I n v esti g at or t o ass ess his/ h er s uit a bilit y f or e ntr y i nt o t h e st u d y 
acc or di n g t o t h e f oll o wi n g i ncl usi o n a n d excl usi o n crit eri a.  
5. 1. 1  
I ncl usi o n Crit eri a 
T o b e i ncl u d e d i n t h e st u d y, s u bj ects m ust m e et all of t h e f oll o wi n g I ncl usi o n Crit eri a: 
 
1.   
M al e or F e m al e, 1 8  t o 7 0  y e ars of a g e (i ncl usi v e)  

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 1 0  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
2.   
Fitz p atr ic k S ki n T y p e I –  VI ( A p p e n dix 3 ) 
3.   
H as visi bl e f at b ul g es ,s ki n l axit y, or c ell ulit e i n t h e tr e at m e nt ar e a 
4.   
N o n -s m o ki n g f or at l e ast 6  m o nt hs a n d willi n g t o r efr ai n fr o m s m o ki n g f or t h e d ur ati o n 
of t h e st u d y . 
5.   
S u bj ect m ust a gr e e t o n ot u n d er g o a n y ot h er pr oc e d ur e(s)  i n t h e tr e at m e nt ar e a d uri n g 
t h e st u d y p eri o d. 
6.   
S u bj ect m ust b e a bl e t o r e a d, u n d erst a n d a n d si g n t h e I nf or m e d C o ns e nt F or m . 
7.   
S u bj ect m ust a d h er e t o t h e f oll o w -u p sc h e d ul e a n d st u d y i nstr ucti o ns . 
8.   
Willi n g t o h a v e di git al p h ot o gr a p hs t a k e n of t h e tr e at m e nt ar e a a n d a gr e e t o u s e of 
p h ot o gr a p hs f or pr es e nt ati o n, e d uc ati o n al or m ar k eti n g p ur p os es.  
9.   
P ost -m e n o p a us al or s ur gic all y st eriliz e d, or usi n g a m e dic all y acc e pt a bl e f or m of birt h 
c o ntr ol at l e ast 3 m o nt hs pri or t o e nr oll m e nt a n d d uri n g t h e e ntir e c o urs e of t h e st u d y, 
a n d n o  pl a ns t o b ec o m e pr e g n a nt.  
5. 1. 2  
E xcl usi o n Crit eri a 
S u bj ects will b e excl u d e d fr o m t h e st u d y if t h e y m e et a n y of t h e f oll o wi n g Excl usi o n Crit eri a: 
 
1.   
P artici p ati o n i n a cli nic al tri al of a n ot h er d e vic e or dr u g  i n t h e t ar g et ar e a d uri n g t h e 
st u d y p eri o d. 
2.   
H as a p ac e m a k er, i nt er n al d efi brill at or , i m pl a nt a bl e c ar di o v ert er-d efi brill at or, n er v e 
sti m ul at or i m pl a nt, c oc hl e ar i m pl a nt or a n y ot h er el ectr o nic all y, 
m a g n etic all y  or 
m ec h a nic all y acti v at e d i m pl a nt.  
3.   
H as m et al i m pl a nt(s) wit hi n t h e b o d y  t h at is l oc al t o t h e tr e at m e nt ar e a, s uc h as s ur gic al 
cli ps, pl at es a n d scr e ws, i ntr a ut eri n e d e vic e (I U D), artifici al h e art v al v es  or artifici al 
j oi nts. 
4.   
Si g nific a nt c o nc urr e nt ill n ess, s uc h as di a b et es m ellit us, c ar di o v asc ul ar dis e as e, 
p eri p h er al v asc ul ar dis e as e or p erti n e nt  n e ur ol o gic al dis or d ers.  
5.   
Di a g n os e d or d oc u m e nt e d i m m u n e s yst e m dis or d ers.  
6.   
Hist or y of a n y dis e as e or c o n diti o n t h at c o ul d i m p air w o u n d h e ali n g.  
7.   
Hist or y of dis e as es sti m ul at e d b y h e at, s uc h as r ec urr e nt h er p es z ost er i n t h e tr e at m e nt 
ar e a, u nl ess tr e at m e nt is c o n d uct e d f oll o wi n g a pr o p h yl actic r e gi m e n. 
8.   
I nf ecti o n, d er m atitis, r as h or ot h er s ki n a b n or m alit y i n t h e t ar g et ar e a. 
9.   
C urr e ntl y u n d er g oi n g s yst e mic c h e m ot h er a p y or r a di ati o n tr e at m e nt f or c a nc er, or 
hist or y of tr e at m e nt i n t h e t ar g et ar e a wit hi n 3 m o nt hs of st u d y p artici p ati o n.  
1 0.   
Pr e g n a nt or c urr e ntl y br e astf e e di n g.  
1 1.   
As p er t h e I n v esti g at or’s discr eti o n, a n y p h ysic al or m e nt al c o n diti o n w hic h mi g ht m a k e 
it u ns af e f or t h e s u bj ect t o p artici p at e i n t his st u dy. 
5. 2  
S u bj ect N u m b eri n g  
E ac h e nr oll e d s u bj ect will b e assi g n e d a s u bj ect I D n u m b er, c o m pris e d of t h e s e q u e nti al n u m b er assi g n e d 
f or e ac h s u bj ect tr e at e d a n d t h e s u bj ect i niti als. T h e s u bj ect i niti als will b e c o m pris e d of t h e first l ett er of 
th e first a n d l ast n a m e.  

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 1 1  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
5. 3  
S u bj ect Disc o nti n u ati o n Crit eri a 
If p ossi bl e, e v er y s u bj ect s h o ul d r e m ai n i n t h e st u d y u ntil c o m pl eti o n of t h e r e q uir e d f oll o w- u p p eri o d. 
H o w e v er, p artici p ati o n i n t his st u d y is c o m pl et ely v ol u nt ar y a n d a s u bj ect c a n c h o os e t o wit h dr a w fr o m 
t h e st u d y at a n y ti m e.  I n a d diti o n, a s u bj ect c a n b e disc o nti n u e d f or a n y of t h e f oll o wi n g r e as o ns: t h e 
Pri nci p al I n v esti g at or d eci d es t h at c o nti n ui n g i n t h e st u d y w o ul d n ot b e i n t h e s u bj ect’s b est i nt er est, a 
s u bj ect is n o nc o m pli a nt wit h t h e pr ot oc ol, a s u bj ect h as a s eri o us r e acti o n t o t h e tr e at m e nt, or t h e st u d y 
is st o p p e d. I n a d diti o n, s u bj ects m a y b e disc o nti n u e d fr o m t h e st u d y if s/ h e d e v el o ps a n y of t h e excl usi o n 
crit eri a d uri n g t h e st u d y p eri o d. A s u bj ect will b e c o nsi d er e d l ost t o f oll o w- u p o nl y aft er t hr e e 
u ns ucc essf ul, d oc u m e nt e d att e m pts t o c o nt act t h e s u bj ect h a v e b e e n m a d e.  Wit h dr a w n s u bj ects will n ot 
b e r e pl ac e d. 
 
6  
S T U D Y P R O C E D U R E S 
A s u m m ar y of all r e q uir e d st u d y pr oc e d ur es a n d ass ess m e nts c a n b e f o u n d i n A p p e n dix 1. 
6. 1  
M e as ur e m e nt T o ols 
M e as ur e m e nt t o ol(s) m ay b e us e d b y a r e pr es e nt ati v e of t h e S p o ns or d uri n g t h e s u bj ect’s tr e at m e nt 
visit t o c oll ect d at a i n t h e s u bj ect’s R F tr e at m e nt ar e a. T h es e m e as ur e m e nt t o ols i ncl u d e, b ut ar e n ot 
li mit e d t o: 
 
T h e s u bj ect m ust pr o vi d e writt e n c o nt e nt pri or t o a n y m e as ur e m e nt t o ol(s) b ei n g us e d, a n d will b e 
o bt ai n e d a n d c oll ect e d o n a s e p ar at e, m e as ur e m e nt t o ol s p ecific c o ns e nt f or m(s), as a p plic a bl e . All 
m e as ur e m e nt t o ols will b e us e d i n acc or d a nc e wit h t h eir I nstr ucti o ns f or Us e (I F Us). 
6. 2  
Scr e e ni n g a n d E nr oll m e nt Visit Pr oc e d ur es 
T h e f oll o wi n g scr e e ni n g pr oc e d ur es will b e p erf or m e d: 
 
1.  I nf or m e d C o ns e nt pr oc ess. 
2.  R e vi e w of s u bj ect m e dic al hist or y. 
3.  Ass ess m e nt of tr e at m e nt ar e a. 
4.  Ass ess m e nt of c o nc o mit a nt m e dic ati o ns. 
5.  
 
 
 
  
6.  T a k e di git al p h ot o gr a p hs of t h e S u bj ect’s t ar g et ar e a (s e e S ecti o n 4. 5)  
6. 3  
R F Tr e at m e nt Visit 
 
T h e R F Tr e at m e nt Visit m a y b e p erf or m e d o n t h e s a m e d a y as t h e Scr e e ni n g a n d E nr oll m e nt Visit as l o n g 
as all of S ecti o n 6. 2  h a v e b e e n c o m pl et e d pri or t o tr e at m e nt. T h e f oll o wi n g pr oc e d ur es will b e p erf or m e d 
at t h e R F  Tr e at m e nt Visit: 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 1 2  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
 
1.  If n e e d e d, cl e a ns e s u bj ect’s tr e at m e nt ar e a wit h a mil d cl e a ns er t o r e m o v e a n y c os m etics , 
p erf u m e or l oti o ns a n d t h e n dr y t h e ar e a. 
2.  Pri or t o p erf or mi n g R F  tr e at m e nt, t h e I n v esti g at or s h o ul d c o nfir m t h e s u bj ect c o nti n u es t o 
m e et t h e st u d y eli gi bilit y crit eri a, 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
1 0
 
 
1 1.  I n v esti g at or will ass ess a n d r ec or d a n y i m m e di at e p ost-tr e at m e nt a d v ers e d e vic e eff ects. 
1 2.  T h e “ B ef or e a n d Aft er Tr e at m e nt I nstr ucti o ns” will b e ex pl ai n e d a n d pr o vi d e d t o t h e s u bj ect 
(s e e A p p e n dix 4). 
 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 1 3  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
6. 4  
8- w e e k a n d 1 2- w e e k F oll o w- U p Visits 
T h e f oll o w- u p visits will occ ur at 8 w e e ks ( ± 2 w e e k) a n d 1 2 w e e ks ( ± 2 w e e k s) p ost-tr e at m e nt. T h e 
f oll o wi n g pr oc e d ur es will b e p erf or m e d at e ac h f oll o w- u p visit: 
 
1.  R e vi e w of s u bj ect m e dic al hist or y. 
2.  Ass ess a n d r ec or d a n y a d diti o ns, c h a n g es a n d/ or d el eti o ns i n pr escri pti o n a n d n o n pr escri pti o n 
c o nc o mit a nt m e dic ati o ns si nc e t h e pr e vi o us st u dy visit.  
 
 
4.  R ec or d s e v erit y a n d d ur ati o n of a n y a d v ers e d e vic e eff ects f oll o wi n g R F tr e at m e nt a n d ass ess 
f or a n y n e w a d v ers e d e vic e eff ects. 
5.  T a k e di git al p h ot o gr a p hs of t h e S u bj ect’s t ar g et ar e a (s e e S ecti o n 4. 5). 
 
  
7  
A D V E R S E D E VI C E E F F E C T S  
7. 1  
D efi niti o ns 
7. 1. 1  
A d v ers e D e vic e Eff ect ( A D E) 
A n a d v ers e d e vic e eff ect ( A D E) is d efi n e d as a n y u nt o w ar d m e dic al occ urr e nc e, u ni nt e n d e d dis e as e or 
i nj ur y, or u nt o w ar d cli nic al si g ns (i ncl u di n g a b n or m al l a b or at or y fi n di n gs) i n s u bj ects, d e vic e us ers or ot h er 
p ers o ns, r el at e d t o t h e i n v esti g ati o n al m e dic al d e vic e ( Fi g ur e 1) . A D Es m a y b e pr e vi o usl y i d e ntifi e d i n 
n at ur e, i nci d e nc e, s e v erit y or o utc o m e i n t h e st u d y pr ot oc ol, i nf or m e d c o ns e nt d oc u m e nt, d e vic e 
o p er at or m a n u al, ot h er ris k a n al ysis d oc u m e nt ati o n or r e g ul at or y a p plic ati o n. 
7. 1. 2  
S eri o us A d v ers e D e vic e Eff ect ( S A D E) 
A s eri o us a d v ers e d e vic e eff ect ( S A D E) is a n y a d v ers e d e vic e eff ect, r el at e d t o t h e us e of a n i n v esti g ati o n al 
d e vic e or cli nic al st u d y d e vic e, t h at: 
 
 l e d t o a d e at h; 
 l e d t o a s eri o us d et eri or ati o n i n t h e h e alt h of t h e s u bj ect t h at:  
 r es ult e d i n a lif e-t hr e at e ni n g ill n ess or i nj ur y; 
 r es ult e d i n a p er m a n e nt i m p air m e nt of a b o d y str uct ur e or b o d y f u ncti o n; 
 r e q uir e d i n- p ati e nt h os pit aliz ati o n or pr ol o n g ati o n of existi n g h os pit aliz ati o n; 
 r es ult e d i n m e dic al or s ur gic al i nt er v e nti o n t o pr e v e nt p er m a n e nt i m p air m e nt t o a b o d y 
str uct ur e or a b o d y f u ncti o n 
 l e d t o f et al distr ess, f et al d e at h or a c o n g e nit al a b n or m alit y or birt h d ef ect. 
7. 1. 3  
A ntici p at e d S eri o us A d v ers e D e vic e Eff ect ( A S A D E) 
A n a ntici p at e d s eri o us a d v ers e d e vic e eff ect ( A S A D E)  is a n y S A D E o n h e alt h or s af et y or a ny lif e-
t hr e at e ni n g pr o bl e m or d e at h c a us e d b y, or ass oci at e d wit h t h e d e vic e, if t h at eff ect, pr o bl e m, or d e at h 
w as pr e vi o usl y i d e ntifi e d i n n at ur e, s e v erit y, or d e gr e e of i nci d e nc e i n t h e i n v esti g ati o n al pl a n, i nf or m e d 
c o ns e nt, o p er at or m a n u al, ot h er ris k a n al ysis d oc u m e nt ati o n or r e g ul at or y a p plic ati o n; or a n y ot h er 
s eri o us pr o bl e m ass oci at e d wit h a d e vic e t h at r el at es t o t h e ri g hts, s af et y, or w elf ar e of s u bj ects.  
 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 1 4  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
Fi g ur e 1. Fl o wc h art f or cl assific ati o n of a d v ers e d e vic e eff ects [ 1 9]  
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
A d v ers e E v e nt Occ urr e nc e                          
(i. e., U nt o w ar d M e dic al Occ urr e nc e)  
Is it d e vic e, 
c o m p ar at or or 
pr oc e d ur e 
r el at e d ? 
 
y es  
A d v ers e D e vic e E v e nt ( A D E)  
- R e p ort e d o n Visit C R F   
- Ex a m pl es: eryt h e m a, e d e m a, br uis e, 1 st a n d 2 n d 
d e gr e e b ur n  
 
 
n o  
A ntici p at e d S eri o us A d v ers e D e vic e Eff ect 
( A S A D E) 
- R e p ort e d o n C ut er a S A D E F or m  
- R e p ort e d o n A D E C R F  
- Ex a m pl es: 3 r d d e gr e e b ur n, e y e d a m a g e fr o m 
l as er 
S eri o us A d v ers e D e vic e 
Eff ect ( S A D E)  
 
U n a ntici p at e d S eri o us A d v ers e D e vic e Eff ect 
( U S A D E/ U A D E) 
- R e p ort e d o n C ut er a S A D E F or m  
- R e p ort e d o n A D E C R F  
- Ex a m pl es: s eiz ur e, ev e nt l e a di n g t o d e at h  
 
 
y es  
n o  
y es  
Is it 
a ntici p at e d ?  
D o es it m e et 
s eri o us n ess 
crit eri a ? 
y es  

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 1 5  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
7. 1. 4  
U n a ntici p at e d S eri o us A d v ers e D e vic e Eff ect ( U S A D E/ U A D E) 
A n  u n a ntici p at e d s eri o us a d v ers e d e vic e eff ect ( U S A D E) is a n y S A D E o n h e alt h or s af et y or a n y lif e-
t hr e at e ni n g pr o bl e m or d e at h c a us e d b y, or ass oci at e d wit h t h e d e vic e, if t h at eff ect, pr o bl e m, or d e at h 
w as n ot pr e vi o usl y i d e ntifi e d i n n at ur e, s e v erity, or d e gr e e of i nci d e nc e i n t h e i n v esti g ati o n al pl a n, 
i nf or m e d c o ns e nt, o p er at or m a n u al, ot h er ris k a n al ysis d oc u m e nt ati o n, or r e g ul at or y a p plic ati o n; or a ny 
ot h er u n a ntici p at e d s eri o us pr o bl e m ass oci at e d wit h a d e vic e t h at r el at es t o t h e ri g hts, s af et y, or w elf ar e 
of s u bj ects.  
 
I n s u bj ects, t h e A D Es/ S A D Es i ncl u d e t h e eff ects r el at e d t o t h e i n v esti g ati o n al m e dic al d e vic e (cli nic al st u dy 
d e vic e), t h e c o m p ar at or or t h e pr oc e d ur es i n v ol v e d. F or d e vic e us ers or ot h er p ers o ns ( ot h er cli nic al st aff 
i n t h e tr e at m e nt r o o m) A D E/ S A D E is r estrict e d t o t h e eff ects r el at e d t o i n v esti g ati o n al m e dic al d e vic es. 
A D Es/ S A D Es m a y i ncl u d e t h e eff ects ( 1) r es ulti n g fr o m i ns uffici e nt or i n a d e q u at e i nstr ucti o ns f or us e, 
d e pl o y m e nt, i nst all ati o n, or o p er ati o n, or a n y m alf u ncti o n of t h e i n v esti g ati o n al m e dic al d e vic e; or ( 2) 
r es ulti n g fr o m us er err or or fr o m i nt e nti o n al mis us e of t h e i n v esti g ati o n al m e dic al d e vic e. 
7. 2  
R ec or di n g A d v ers e D e vic e Eff ects 
All p ot e nti al A D Es will b e e v al u at e d a n d m ust b e r ec or d e d i n t h e s u bj ect’s m e dic al c h art a n d i n t h e st u dy 
c as e r e p ort f or ms. A D Es will b e m o nit or e d a n d tr ac k e d fr o m t h e ti m e of t h e first R F tr e at m e nt.  
 
At e ac h c o nt act wit h t h e s u bj ect, t h e I n v esti g at or will s e e k i nf or m ati o n o n A D Es b y s p ecific q u esti o ni n g 
a n d, as a p pr o pri at e, b y ex a mi n ati o n. A D Es m a y b e o bs er v e d b y t h e I n v esti g at or a n d/ or cli nic al r es e arc h 
st aff, elicit e d fr o m t h e s u bj ect a n d/ or f a mil y m e m b er or v ol u nt e er e d b y t h e s u bj ect. All o bs er v e d a n d 
v ol u nt e er e d a d v ers e si g ns a n d s y m pt o ms ( b ot h ex p ect e d a n d u n ex p ect e d), r e g ar dl ess of s e v erit y or 
fr e q u e ncy, will b e r ec or d e d i n t h e c as e hist ori es ( m e dic al c h art a n d C R Fs). I ncl u d e d i n t h e d escri pti o n 
s h o ul d b e t h e n at ur e of t h e si g n or s y m pt o m, t h e d at e of o ns et, d at e of r es ol uti o n ( d ur ati o n), t h e s ev erit y, 
w h et h er t h e e v e nt w as ex p ect e d or u n ex p ect e d ( a ntici p at e d or u n a ntici p at e d), t h e r el ati o ns hi p t o st u dy 
tr e at m e nt or ot h er t h er a p y, t h e acti o n t a k e n (if a n y), a n d t h e o utc o m e.  
 
All S A D Es a n d U A D Es m ust b e r e p ort e d acc or di n g t o C ut er a a n d I R B r e q uir e m e nts. 
7. 3  
F oll o w- u p of S u bj ects aft er A D Es 
All r e p ort e d A D Es s h o ul d b e f oll o w e d u ntil r es ol uti o n or u ntil t h e s u bj ect’s p artici p ati o n i n t h e st u d y e n ds.  
R es ol uti o ns of s uc h e v e nts ar e t o b e d oc u m e nt e d o n t h e a p pr o pri at e C R F p a g es.  All A D Es t h at r es ult i n 
p er m a n e nt disc o nti n u ati o n fr o m t his cli nic al tri al, w h et h er s eri o us or n ot, will als o b e r e p ort e d o n t h e 
S u bj ect N o n- C o m pl eti o n of St u d y F or m. 
8  
P O T E N TI AL RI S K S / B E N E FI T S 
8. 1  
P ot e nti al Ris ks 
T h e k n o w n ris ks a n d a d v ers e d e vic e eff ects ass oci at e d wit h t h e st u d y d e vic e or tr e at m e nt pr oc e d ur e ar e 
s h o w n i n T a bl e 3 . 
 
 
 
 
 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 1 6  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
T a bl e 3.  P ot e nti al St u d y Ris ks 
 
P ot e nti al St u d y Ris ks or A D Es/ S A D Es  

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 1 7  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
8. 2  
P ot e nti al B e n efits 
T h e s u bj ects m a y or m a y n ot b e n efit fr o m t h e tr e at m e nt. P ot e nti al b e n efits i ncl u d e i m pr o v e d a p p e ar a nc e 
of t h e tr e at e d ar e a. T h er e is n o g u ar a nt e e of s ucc ess.  
8. 3  
Ris k M a n a g e m e nt 
T h e I n v esti g at or c h os e n f or t his st u d y will h a v e ext e nsi v e a n d s af e ex p eri e nc e wit h t h e us e of R F syst e ms 
i n d er m at ol o g y a p plic ati o ns. T his is t h e m ost critic al el e m e nt i n m a n a gi n g s u bj ect ris k. I n a d diti o n, t h e 
I n v esti g at ors will b e tr ai n e d o n t h e us e of t h e C ut er a R F d e vic e a n d a n y i nv esti g ati o n al h a n d pi ec es. 
9  
D A T A A N AL Y SI S PL A N  
9. 1  
S a m pl e Siz e 
U p t o 4 0 s u bj ects will b e e nr oll e d i n t his f e asi bilit y st u d y. 
9. 2  
A n al ysis S ets 
T h e effic ac y a n al ysis s et will i ncl u d e all e nr oll e d s u bj ects w h o c o m pl et e t h e R F  tr e at m e nt s essi o n usi n g 
t h e st u d y d e vic e. 
 
T h e s af et y a n al ysis s et will i ncl u d e all s u bj ects e nr oll e d i n t h e st u d y w h o st art t h e R F  tr e at m e nt s essi o n 
usi n g t h e st u d y d e vic e. 
 
Missi n g d at a will n ot b e i m p ut e d f or effic ac y or s af et y e n d p oi nts. 
9. 3  
A n al ysis of Effic ac y E n d p oi nts 
9. 3. 1  
Pri m ar y E n d p oi nt A n al ysis 
F o r m al h y p ot h esis t esti n g a n d st atistic al a n al ysis ar e  n ot pl a n n e d f or t his st u d y. T h e pri m ar y effic ac y 
e n d p oi nt d at a will b e s u m m ariz e d d escri pti v el y 
  
 
T h e pri m ar y effic acy e n d p oi nt is:    
 
 D e gr e e of i m pr o v e m e nt i n t h e tr e at e d ar e a at 1 2 w e e ks p ost-tr e at m e nt as ass ess e d b y t h e 
I n v esti g at or. 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 1 8  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
9. 4  
S af et y A n al ys es 
D e vic e-r el at e d a n d pr oc e d ur e-r el at e d a d v ers e eff ects ( A Es) a n d s u bj ects w h o pr e m at ur el y t er mi n at e fr o m 
t h e st u d y d u e t o a n a d v ers e d e vic e eff ect, 
will b e t a b ul at e d 
a n d a n al yz e d. F or a gi v e n A E t er m, c o u nti n g will b e d o n e b y s u bj ect, n ot b y e v e nt, i. e. f or a s u bj ect 
r e p orti n g t h e s a m e A E m or e t h a n o nc e, t h e e v e nt will b e c o u nt e d o nl y o nc e, at t h e m ost s e v er e a n d 
l o n g est d ur ati o n.  T h e n u m b er a n d p erc e nt a g e of s u bj ects ex p eri e nci n g e ac h A E T er m will b e d escri pti v el y 
s u m m ariz e d. 
 
1 0  S U BJ E C T P A Y M E N T 
 
 
1 1  S T U D Y M A N A G E M E N T A N D A D MI NI S T R A TI V E P R O C E D U R E S  
1 1. 1  Tr ai ni n g a n d M o nit ori n g 
T h e i n v esti g at ors a n d sit e r es e arc h st aff will b e tr ai n e d o n t h e st u d y pr oc e d ur es. S p o ns or r e pr es e nt ati v e(s) 
m a y b e pr es e nt at t h e sit e d uri n g t h e tr e at m e nts t o e ns ur e t h at all pr oc e d ur es a n d d oc u m e nt ati o n ar e i n 
pl ac e.  
 
I n v esti g at or 
will all o w s p o ns or r e pr es e nt ati v es t o p eri o dic all y r e vi e w t h e st u d y d oc u m e nt ati o n.  
M o nit ori n g of t h e sit e will occ ur at r e g ul ar i nt er v als t o e v al u at e t h e pr o gr ess of t h e st u d y, v erif y t h e 
acc ur ac y a n d c o m pl et e n ess of C R Fs a g ai nst s u bj ect s o urc e d oc u m e nt ati o n, ass ur e t h at all pr ot oc ol 
r e q uir e m e nts, a p plic a bl e F D A r e g ul ati o ns a n d t h e i n v esti g at or’s o bli g ati o ns ar e b ei n g f ulfill e d a n d r es ol v e 
a n y i nc o nsist e nci es i n t h e st u d y r ec or ds.  
1 1. 2  I nf or m e d C o ns e nt 
T h e i n v esti g at or is r es p o nsi bl e f or e ns uri n g t h at writt e n i nf or m e d c o ns e nt, usi n g a n I nstit uti o n al R e vi e w 
B o ar d (I R B) a p pr o v e d i nf or m e d c o ns e nt d oc u m e nt, is o bt ai n e d fr o m e ac h s u bj ect b ef or e t h e p erf or m a nc e 
of a n y pr ot oc ol pr oc e d ur es, i ncl u di n g a d mi nistr ati o n of t h e st u d y d e vic e. T h e i nf or m e d c o ns e nt d oc u m e nt 
m ust c o m pl y wit h all ess e nti al el e m e nts as d efi n e d i n 2 1 C F R 5 0. 2 5 “ El e m e nts of I nf or m e d C o ns e nt” a n d 
m ust c o nt ai n a st at e m e nt t h at c o ns e nt is fr e el y giv e n, t h e st u d y i n v ol v es r es e arc h, t h e s u bj ect is a w ar e of 
t h e ris ks a n d b e n efits of e nt eri n g t h e st u d y, a n d t h at t h e s u bj ect is fr e e t o wit h dr a w fr o m t h e st u d y at a n y 
ti m e.  A n e v al u ati o n of e ac h c a n di d at e will b e c o n d uct e d b y t h e i n v esti g at or. U p o n d et er mi ni n g a s u bj ect’s 
eli gi bilit y st at us, t h e s u bj ect will b e off er e d t h e o p p ort u nit y t o p artici p at e i n t h e st u d y.  
 
T h e i n v esti g at or or t h e i n v esti g at or’s d esi g n e e will i nf or m all s u bj ects r e g ar di n g t h e p ur p os e of t h e st u d y 
a n d ex p ect e d d ur ati o n, as w ell as t h e p ot e nti al risks a n d b e n efits t h at m a y r es ult fr o m p artici p ati o n. T h e 
s u bj ects s h all b e i nf or m e d b y t h e i n v esti g at or or i n v esti g at or’s d esi g n e e t h at t h e y ar e fr e e t o r ef us e 
p artici p ati o n i n t his cli nic al st u d y. If t h e y el ect t o p artici p at e, it will b e m a d e cl e ar t h at t h e y m a y wit h dr a w 
fr o m t h e st u d y at a n y ti m e wit h o ut pr ej u dici n g f urt h er c ar e.  
 
T h e s u bj ects will als o b e i nf or m e d of alt er n ati v e m et h o ds of tr e at m e nt s h o ul d t h e y n ot wis h t o p artici p at e 
i n t h e st u d y.  
 
T h e s u bj ects will b e gi v e n t h e o p p ort u nit y t o disc uss t h e pr oc e d ur e, ris ks, b e n efits, alt er n ati v e t h er a pi es, 
a n d t h e st u d y r e q uir e m e nts wit h t h e i n v esti g at or a n d h a v e a n y a n d all q u esti o ns a ns w er e d t o t h e s u bj ects’ 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 1 9  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
s atisf acti o n. A si g n e d a n d d at e d i nf or m e d c o ns e nt f or m m ust b e o bt ai n e d fr o m t h e s u bj ect b y t h e 
I n v esti g at or or t h e I n v esti g at or’s d esi g n e e pri or t o a s u bj ect’s i n v ol v e m e nt i n t h e st u d y.  
 
T h e ac q uisiti o n of i nf or m e d c o ns e nt will b e d oc u m e nt e d i n t h e s u bj ect’s m e dic al r ec or ds, as r e q uir e d b y 
2 1 C F R 8 1 2. 1 4 0. A c o p y of t h e c o ns e nt f or m will b e gi v e n t o t h e s u bj ect. T h e ori gi n al c o ns e nt f or ms will 
b e k e pt i n t h e C R F bi n d er b y t h e i n v esti g at or a n d will b e s u bj ect t o r e vi e w b y C ut er a or a r e pr es e nt ati v e 
of C ut er a, a n d b y a p pr o pri at e r e g ul at or y b o di es.  
1 1. 3  Pr ot oc ol C o m pli a nc e 
T h e pri nci p al i n v esti g at or m ust c o m pl y wit h all t er ms of t h e pr ot oc ol. 
1 1. 3. 1  Pr ot oc ol A m e n d m e nts 
N eit h er t h e pri nci p al i n v esti g at or n or t h e s p o ns or will m o dif y or alt er t his pr ot oc ol wit h o ut first o bt ai ni n g 
t h e c o nc urr e nc e of t h e ot h er p art y ( wit h t h e exc e pti o n of a m e n d m e nts w hic h i n v ol v es miti g ati n g a 
m e dic al e m er g e ncy or i m m e di at e h e alt h ris k t o t h e s u bj ect). T h e p art y i niti ati n g a n a m e n d m e nt m ust 
c o nfir m it cl e arl y i n writi n g a n d it m ust b e si g n e d a n d d at e d b y t h e s p o ns or a n d t h e pri nci p al i n v esti g at or. 
I R B a p pr o v al m ust b e o bt ai n e d b ef or e i m pl e m e nt ati o n of a n a m e n d m e nt. 
1 1. 3. 2   Pr ot oc ol D e vi ati o ns 
All pr ot oc ol d e vi ati o ns m ust b e cl e arl y d escri b e d o n t h e c as e r e p ort f or m (i. e., C ut er a Pr ot oc ol D e vi ati o n 
F or m). D e vi ati o ns fr o m t h e pr ot oc ol m a y i ncl u d e b ut ar e n ot li mit e d t o s u bj ect’s f ail ur e t o att e n d 
sc h e d ul e d visit d uri n g a visit wi n d o w, us e of o ut of r a n g e tr e at m e nt p ar a m et ers a n d i nc o m pl et e or 
i nc orr ect st u d y pr oc e d ur es. A n y m e dic al e m er g e ncy or i m m e di at e h e alt h ris k t o t h e s u bj ect w hic h r es ults 
i n a pr ot oc ol d e vi ati o n a n d m ust b e r e p ort e d t o t h e s p o ns or wit hi n 5 w orki n g d a ys 
 
Si g nific a nt pr ot oc ol d e vi ati o ns m ust b e r e p ort e d t o I R B acc or di n g t o t h eir p olici es. 
1 1. 4  St u d y P ers o n n el 
Pri or t o t h e st art of t h e st u d y, t h e i n v esti g at or m ust s u p pl y t h e s p o ns or wit h a list of t h e n a m es a n d 
c urric ul a vit a e t h at d escri b e t h e pr of essi o n al b ac k gr o u n ds of t h e cli nic all y r es p o nsi bl e st u d y i n v esti g at ors 
( pri nci p al, s u b-i n v esti g at ors), r es e arc h n urs es, a n d ot h er p ossi bl e p artici p a nts ( e. g. m e dic al d oct or, n urs e, 
etc.). 
1 1. 5  Discl os ur e of Fi n a nci al I nt er est 
E ac h i n v esti g at or [ pri nci p al a n d s u b-i n v esti g at or(s)] is r e q uir e d t o discl os e s uffici e nt acc ur at e fi n a nci al 
i nf or m ati o n t o t h e s p o ns or, t o all o w s p o ns or t o s u b mit c o m pl et e a n d acc ur at e c ertific ati o n or discl os ur e 
st at e m e nts. 
1 1. 6  D at a C oll ecti o n, R ec or d K e e pi n g a n d St or a g e 
T h e pri nci p al i n v esti g at or is r es p o nsi bl e f or ass uri n g t h at all st u d y r ec or ds i ncl u di n g c as e r e p ort f or ms 
( C R Fs), i nf or m e d c o ns e nt f or ms, d e vic e acc o u nt a bilit y r ec or ds, s o urc e d oc u m e nts ( e. g., m e dic al r ec or ds, 
hist ol o g y r e p orts etc.) a n d ot h er st u d y r ec or ds ar e c o m pl et e, acc ur at e a n d r ec or d e d i n a ti m el y m a n n er.  
 
C R Fs s h o ul d n ot b e t h e o nl y r ec or d of a p ati e nt’s p artici p ati o n i n t h e st u d y a n d will b e us e d f or tr a nscri bi n g 
d at a fr o m s o urc e d oc u m e nts w hic h ar e t h e p oi nt of first e ntr y of d at a c oll ect e d f or e ac h s u bj ect ( wit h t h e 
exc e pti o n of d oc u m e nts list e d u n d er B ). T h e i n v esti g at or or r es e arc h st aff at t h e sit e will e ns ur e t h at: 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 2 0  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
 
A.   
S o urc e d oc u m e nt ati o n t h or o u g hl y a n d a d e q u at el y d oc u m e nte d :  
 
1.  T h at p ati e nt is p artici p ati n g i n a cli nic al st u d y a n d h as b e e n pr o p erl y i nf or m e d a n d c o ns e nt e d 
pri or t o p artici p ati o n i n t h e st u d y,  
2.  M e dic al hist or y,  
3.  C o nc o mit a nt m e dic ati o ns,  
4.  P ati e nt’s c o n diti o n u p o n e nt eri n g a n d d uri n g t h e c o urs e of t h e st u d y,  
5.  A n y a d v ers e e v e nt(s) t h at mi g ht h a v e occ urr e d (i n a d diti o n t o t h e Visit C R Fs a n d/ or A d v ers e 
D e vic e Eff ect C R F a n d/ or C ut er a S A D E f or m c o m pl et e d),  
6.  R es ults of a n y di a g n ostic t ests/ hist ol o g y c o n d uct e d d uri n g t h e st u d y. 
 
B.   
T h e f oll o wi n g d at a will b e r ec or d e d dir ectl y o nt o C R Fs: 
 
7.  P ati e nt m e ets st u d y i ncl usi o n a n d excl usi o n crit eri a, 
8.  A r ec or d of t h e tr e at m e nt p ar a m et ers, i ncl u di n g t h e d at e of e ac h R F  tr e at m e nt a n d a n y ot h er 
a dj u nct t h er a p y, 
9.  A n y pr ot oc ol d e vi ati o ns, 
 
1 1.  St u d y r el at e d i m pr o v e m e nt ass ess m e nts b y t h e i n v esti g at or or i n v esti g at or’s d esi g n e e,  
 
 
C.   
T h e f oll o wi n g d oc u m e nts will b e m ai nt ai n e d i n t h e st u d y r ec or ds: 
 
1 3.  T h e I n v esti g at or or t h e r es e arc h st aff will c h ec k si g n e d i nf or m e d c o ns e nt f or acc ur ac y a n d will 
al w a ys k e e p t h e ori gi n al c o p y of t h e si g n e d i nf or m e d c o ns e nt i n t h e C R F bi n d er.  
1 4.  All c orr es p o n d e nc e wit h a n I nstit uti o n al R e vi e w B o ar d (I R B), t h e s p o ns or, or F D A i ncl u di n g 
r e q uir e d r e p orts will als o b e r et ai n e d i n t h e st u d y r ec or ds.  
1 5.  R ec or ds of r ec ei pt, us e or dis p ositi o n of t h e i n v esti g ati o n al d e vic e. 
 
All d at a e ntri es o n t h e C RFs will b e r ec or d e d c o m pl et el y, pr o m ptl y, a n d l e gi bl y usi n g bl u e or bl ac k i n d eli bl e 
i n k p e n a n d acc ur ac y will b e e ns ur e d. T h e c orr ecti o ns o n C R Fs will b e m a d e o nl y b y t h e i n v esti g at or or t h e 
d oc u m e nt e d i n v esti g at or’s d esi g n e e. T o m a k e a c orr ecti o n t o a n e ntr y, t h e d at a will b e cr oss e d t hr o u g h 
wit h a si n gl e li n e (t h e ori gi n al e ntr y s h o ul d b e visi bl e) a n d t h e n will b e i niti al e d a n d d at e d b y t h e p ers o n 
m a ki n g t h e c orr ecti o n.  
 
T h e st u d y r ec or ds will b e m ai nt ai n e d i n a s ec ur e l oc ati o n t hr o u g h o ut t h e d ur ati o n of t h e st u d y.  U p o n 
st u d y c o m pl eti o n or t er mi n ati o n, r ec or ds will b e k e pt at a s ec ur e l oc ati o n u ntil at l e ast 2 y e ars aft er t h e 
l ast a p pr o v al of a m ar k eti n g a p plic ati o n a n d u ntil t h er e ar e n o p e n di n g or c o nt e m pl at e d m ar k eti n g 
a p plic ati o ns or at l e ast 2 y e ars h a v e el a ps e d si nc e t h e f or m al disc o nti n u ati o n of cli nic al d e v el o p m e nt of 
t h e i n v esti g ati o n al pr o d uct.  
1 1. 7  S u bj ect C o nfi d e nti alit y 
T his st u d y pr es er v es t h e c o nfi d e nti alit y of all s u bj ects u n d er t h e H e alt h I ns ur a nc e P ort a bility a n d 
Ac c o u nt a bilit y Act of 1 9 9 6 ( HI P A A) Pri v acy R ul e. T h e f oll o wi n g s af e g u ar ds will b e i n pl ac e t o pr ot ect t h e 
pri v acy of t h e i n di vi d u als w h o ar e t h e s u bj ects of t h e h e alt h i nf or m ati o n t o b e us e d i n t h e r es e arc h a n d 
t h e c o nfi d e nti alit y of t h at i nf or m ati o n:   

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 2 1  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
 
T h e s u bj ects will b e i nf or m e d b y t h e i n v esti g at or or t h e i n v esti g at or’s d esi g n e e t h at t h eir m e dic al r ec or ds 
will b e k e pt as c o nfi d e nti al as p ossi bl e b ut m a y b e s u bj ect t o r e vi e w b y: ( 1) C ut er a, or its r e pr es e nt ati v e; 
( 2) r e vi e wi n g I R B; a n d/ or ( 3) b y a p pr o pri at e r e g ul at or y b o di es ( e. g. t h e U S F o o d a n d Dr u g A d mi nistr ati o n 
( F D A), D e p art m e nt of H e alt h a n d H u m a n S er vic es ( D H H S) a g e nci es).  
 
O nl y pi ec es of p ers o n al i nf or m ati o n r e q uir e d f or p ur p os es of t h e st u d y will b e c oll ect e d. T h e p ers o n al 
i nf or m ati o n will b e c oll ect e d a n d us e d t o e ns ur e s u bj ect eli gi bilit y f or st u d y p artici p ati o n, t o c o n d uct t h e 
st u d y a n d t o ass ess t h e r es ults of t h e st u d y as r e q uir e d a n d p er mitt e d b y l a w. S u bj ects h a v e t h e ri g ht t o 
s e e a n d c o p y a n y of t h e i nf or m ati o n g at h er e d a b o ut t h e m a n d r e q u est c h a n g es if t h e i nf or m ati o n is n ot 
c orr ect, u ntil it is n o l o n g er k e pt b y t h e i n v esti g at or. P er missi o n t o us e or discl os e p ers o n al i nf or m ati o n, 
exc e pt f or t h at h as b e e n c oll ect e d a n d r eli e d o n m a y b e c a nc ell e d b y t h e s u bj ect b y writt e n n otic e. If t h e 
s ubj ect is wit h dr a w n fr o m t h e st u d y, t h e i nf or m ati o n c oll ect e d t o t h at ti m e m a y still b e us e d t o pr es er v e 
t h e sci e ntific i nt e grit y of t h e st u d y. T h er e is n o ex pir ati o n d at e t o t his a ut h oriz ati o n.  
 
S u bj ects’ i d e ntiti es will b e k e pt c o nfi d e nti al. S u bj ects wil l b e assi g n e d a u ni q u e st u d y c o d e t h at will n ot 
r e v e al t h e s u bj ects’ i d e ntit y, a n d t his c o d e will b e us e d o n all st u d y d oc u m e nts. T o pr ot ect s u bj ect i d e ntity 
wit h r e g ar ds t o t h e p h ot o gr a p hs t a k e n of t h e tr e at m e nt ar e as, c ar e will b e t a k e n t o c o v er ar e as of 
p h ot o gr a p hs t o pr ot ect i d e ntit y. T ec h ni q u es s uc h as c o v eri n g of e y es o n f ull f ac e p h ot o gr a p hs, cr o p pi n g 
off p orti o ns of t h e f ac e i n cl os e- u p p h ot os will b e us e d t o o bsc ur e i d e ntif yi n g c h ar act eristics i n 
p h ot o gr a p hs. T h e r es ults of r es e arc h, i ncl u di n g p h ot o gr a p hs, m a y b e p u blis h e d i n sci e ntific j o ur n als, 
pr es e nt e d at m e dic al m e eti n gs, a n d us e d i n tr ai ni n g a n d m ar k eti n g m at eri als b ut s u bj ect i d e ntiti es will 
n ot b e discl os e d.  
1 1. 8  P u blic ati o n P olic y 
T h e i n v esti g at or s h all h av e t h e ri g ht t o p u blis h t h e r es ults of t h e st u d y. U nl ess m ut u all y a gr e e d u p o n i n 
writi n g, pri or t o s u b missi o n f or p u blic ati o n of a n y m a n uscri pt, p ost er, pr es e nt ati o n, a bstr act or ot h er 
writt e n or or al m at eri al d escri bi n g t h e r es ults of t h e st u d y, t h e i n v esti g at or s h all all o w s p o ns or t o r e vi e w 
m a n uscri pt, p ost er pr es e nt ati o n, a bstr act or ot h er writt e n or or al m at eri al w hic h d escri b es t h e r es ults of 
t h e st u d y f or t h e p ur p os e o nl y of d et er mi ni n g if a n y p at e nt a bl e i nf or m ati o n is discl os e d. At t h e s p o ns or’s 
r e q u est, t h e i n v esti g at or s h all wit h h ol d a n y p u blic ati o n or pr es e nt ati o n t o p er mit s p o ns or t o s e e k p at e nt 
pr ot ecti o n a n d t o r e m o v e a n y c o nfi d e nti al i nf or m ati o n fr o m all p u blic ati o ns.  
 
T h e I nt er n ati o n al C o m mitt e e of M e dic al J o ur n al E dit ors (I C MJ E) m e m b er j o ur n als h a v e a d o pt e d a tri als 
r e gistr ati o n p olic y as a c o n diti o n f or p u blic ati o n. T his p olic y r e q uir es t h at all cli nic al tri als b e r e gist er e d i n 
a p u blic tri als r e gistr y s uc h as Cli nic al Tri als. g o v, w hic h is s p o ns or e d b y t h e N ati o n al Li br ar y of M e dici n e. I t 
is t h e r es p o nsi bilit y of t h e s p o ns or t o r e gist er t his tri al i n Cli nic al Tri als. g o v. A n y cli nic al tri al st arti n g 
e nr oll m e nt aft er S e pt e m b er 2 7, 2 0 0 7 m ust b e r e gist er e d eit h er o n or b ef or e t h e o ns et of p ati e nt 
e nr oll m e nt. 
 
 
 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 2 2  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
R E F E R E N C E S  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 2 3  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 2 5  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
 
 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 2 6  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
A p p e n di x 3 : Fitz p atric k S ki n T y p e Cl assific ati o n 
 
 
 
 
 
 
 
 

C ut er a, I nc. 
Pr ot oc ol # C- 1 6 - T S 1 2 
“F e asi bilit y St u dy of t h e Tr u Sc ul pt R a di ofr e q u e nc y D evic e ” 
 
C o nfi d e nti al a n d Pr o pri et ary 
                                            P a g e 2 7  of 2 8                                                        V ersi o n 2. 0, 0 5 J a n 2 0 1 7 
A p p e n di x 4:  B ef or e a n d Aft er Tr e at m e nt I nstr ucti o ns 
 
B ef or e Tr e at m e nt I nstr ucti o ns: 
 
 
 
 
    
 
 
Aft er Tr e at m e nt C ar e I nstr ucti o ns: