May 4, 2018
Ulthera, Inc
Mr. Steven J. Kachelmeyer
Executive Director, Regulatory Affairs
1840 South Stapley Drive Suite 200
Mesa, Arizona 85204
Re: K180623
Trade/Device Name: Ulthera System
Regulation Number: 21 CFR 878.4590
Regulation Name: Focused Ultrasound Stimulator System for Aesthetic Use
Regulatory Class: Class II
Product Code: OHV, IYO
Dated: March 7, 2018
Received: March 9, 2018
Dear Mr. Kachelmeyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in theenclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, theenactment date of the Medical Device Amendments, or to devices that have been reclassified in accordancewith the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of apremarket approval application (PMA). You may, therefore, market the device, subject to the generalcontrols provisions of the Act. The general controls provisions of the Act include requirements for annual
registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandingand adulteration. Please note: CDRH does not evaluate information related to contract liability warranties.
We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may besubject to additional controls. Existing major regulations affecting your device can be found in the Code ofFederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act'srequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
1000-1050.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID# 04017.02.08

Page 2 – Ms. Jessica Newhard

K180623

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry andConsumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone(1-800-638-2041 or 301-796-7100).
Sincerely,yJennifer R.
Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director
Division of Surgical Devices
Office of Device Evaluation
Center for Devices andRadiological Health
EnclosureDEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020

Indications for Use

See PRA Statement below.

510(k) Number (if known)

K180623
Device Name

Ulthera System

Indications for Use (Describe)

The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to:• lift the eyebrow• lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental
and neck regions• improve lines and wrinkles of the décolleté

The Ulthera® System in conjunction with the Ulthera® DeepSEE transducer allows for ultrasonic visualization of depths
up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layersof tissue to:• ensure proper coupling of the transducer to the skin
• confirm appropriate depth of treatment such as to avoid boneType of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:Department of Health and Human Services
Food and Drug Administration
Office of Chief Information OfficerPaperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov“An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number.”
FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740

EFK180623
Page 1 of 3510(K) SUMMARY
Applicant:Address:
Contact:
Telephone:
Fax:

Ulthera®, Inc.
1840 South Stapley Drive, Suite 200
Mesa, AZ 85204
Steven J. Kachelmeyer - Executive Director, Regulatory Affairs(480) 619-4069(480) 619-4071

Date Prepared: May 2, 2018
Device Trade Name: Ulthera® System
Common Name: Focused Ultrasound for Tissue Heat or Mechanical Cellular Disruption
System, Imaging, Pulsed Echo, UltrasonicClassification Name: 21 C.F.R. § 878.4590, Focused Ultrasound Stimulator Use
System for Aesthetic Use
Regulatory Class: Class II
Product Codes: OHV, IYO
Predicate Device: Ulthera®, Inc. Ulthera® System (K134032)
Applicable Guidance: Class II Special Controls Guidance Document: Focused UltrasoundStimulator System for Aesthetic Use.
The device also conforms to Guidance for Industry and FDA Staff: Information for
Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems andTransducers and Guidance for the Content of Premarket Submissions for Software Containedin Medical Devices.
Device Description: The Ulthera® System consists of the Ulthera® Control Unit (with systemsoftware), a handpiece with cable, and interchangeable transducers. The device produces
controlled tissue coagulation below the skin surface (epidermis) within the first few
millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. TheUlthera® System directs micro-focused acoustic waves to the treatment area at desired depths
without affecting or requiring a secondary action to protect the skin surface. The operator
may also use the device’s supplemental imaging capability to visualize the treatment area andaid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in thetarget area.
Indications for Use: The Ulthera® System is indicated for use as a non-invasive
dermatological aesthetic treatment to:lift the eyebrow
lift lax submental (beneath the chin) and neck tissue; which can also affect theappearance of lax tissue in the submental and neck regions
improve lines and wrinkles of the décolleté1

K180623
Page 2 of 3®
®
The Ulthera System in conjunction with the Ulthera DeepSEE transducer allows forultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated useof the imaging is to visualize the dermal and subdermal layers of tissue to:• ensure proper coupling of the transducer to the skin
• confirm appropriate depth of treatment such as to avoid bone
Summary of Technological Characteristics: High Intensity Focused Ultrasound (HIFU) isthe underlying technological principle for both the subject and predicate devices. The Ulthera®
System functions by directing ultrasonic energy beneath the outer dermis in localized points ata specified distance and depth between points. The design and performance characteristics of thesubject and predicate devices are identical. The only technological differences between thedevices are minor and do not raise different questions of safety or effectiveness for the subject
device as compared to the predicate.
A table comparing the key features of the subject and predicate devices is provided below.

Regulation

Predicate Device: Ulthera® System(K134032)
21 C.F.R. § 878.4590

Subject Device: Ulthera® System,
Expanded Indications for Use
21 C.F.R. § 878.4590

Product CodeOHV, IYOOHV, IYO

Intended Use/
Indications for
Use

Non-invasive dermatological aesthetic
treatment to:• lift the eyebrow• lift lax submental (beneath the chin) andneck tissue• improve lines and wrinkles of thedécolleté

Non-invasive dermatological aesthetic
treatment to:• lift the eyebrow• lift lax submental (beneath the chin)and neck tissue which can also affect theappearance of lax tissue in thesubmental and neck regions• improve lines and wrinkles of theThe Ulthera® System in conjunction with
décolleté®
the Ulthera DeepSEE transducer allows
for ultrasonic visualization of depths up to
8 mm below the surface of the skin. TheThe Ulthera® System in conjunction withindicated use of the imaging is to visualize
the Ulthera® DeepSEE transducer allows
the dermal and subdermal layers of tissue
for ultrasonic visualization of depths up toto:
8 mm below the surface of the skin. The• ensure proper coupling of theindicated use of the imaging is totransducer
visualize the dermal and subdermal
to the skinlayers of tissue to:• confirm appropriate depth of•ensure proper coupling of the transducer
treatment such as to avoid boneto the skin•confirm appropriate depth of treatment
such as to avoid bone
Where Used
Anatomical Site
Type of Energy
Biological EffectPatient Contact
Material

Clinic/doctor’s office
Skin
Thermal, < 2 J
Lifting of tissue and reduction of lines andwrinkles via High Intensity Focused
Ultrasound (HIFU) directed beneath theouter dermis in localized points at a
specified depth and distance between
Biocompatible

Clinic/doctor’s office
Skin
Thermal, < 2 J
Lifting of tissue and reduction of lines andwrinkles via High Intensity Focused
Ultrasound (HIFU) directed beneath theouter dermis in localized points at a
specified depth and distance between
Biocompatible2K180623
Page 3 of 3
MedicalCompliant with relevant standards
ElectricalEquipment
Safety and EMC

Compliant with relevant standards

ThermalCoagulation
Point
Epidermal
ImpactPigmentation
EffectSystemSoftware

Shallow (< 5 mm) and confined – nothermal coagulation below focal zone.

Shallow (< 5 mm) and confined – nothermal coagulation below focal zone.

Non-invasive; no cooling required

Non-invasive; no cooling required

Chromophore insensitive

Chromophore insensitive

Version 1382

Version 1700 – minor software updates tohave GUI match cleared labeling inK134032, add improved security fortransducer detection, and correct minor
anomalies.
Integrated Instructions for Use(IFU) andTechnical Information Manual (TIM) into asingle document to simplify translations.
Added UDI labeling
Updated symbols for IEC 60601-1-3.1 ed.
Control Unit and Handpiece: CorrugatedcartonTransducer: Nylon / Aluminum foil
laminate bag with very low water vapor
transmission rate, enclosed within aNon-sterile
Controller and handpiece: Reusable
Transducers: Single-use
12 months (transducer)

Device Labeling Instructions for Use(IFU) and Technical
Information Manual (TIM) shipped as two
separate documents

Packaging

Sterilization
Single-use/Reusable
Shelf Life

Control Unit and Handpiece: CorrugatedcartonTransducer: Nylon / Aluminum foil
laminate bag with very low water vapor
transmission rate, enclosed within a
Non-sterile
Controller and handpiece: Reusable
Transducers: Single-use
12 months (transducer)

Performance Data: To support the expanded indication, the Ulthera® System was evaluated in
an open-label clinical trial investigating the clinical response following treatment with theUlthera® System to achieve lifting of lax submental (beneath the chin) and neck tissue.
Improvement was evaluated through quantitative assessment, qualitative assessment and patientsatisfaction questionnaires. There were 51/70 patients that had an improvement of ≥20 mm2 inlift, of these patients 84.3% were identified as showing improvement by masked evaluators.
The adverse events resulting from treatment with the Ulthera® System during this study weremild, short-lived in duration, and resolved without incident. There were no serious adverse
events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment with theUlthera® System.
Conclusion: The Ulthera® System is as safe and effective as the predicate Ulthera® System
cleared by FDA in K134032. The subject device has the same intended use and very
similar technological characteristics and principles of operation as its predicate device. The
minor differences in indications do not alter the intended therapeutic use of the device, and do
not affect its safety and effectiveness when used as labeled. In addition, the minor
technological differences between the subject Ulthera® System and its predicate raise no new
types of safety or effectiveness questions. Thus, the Ulthera® System with modified
indications for use is substantially equivalent to the legally marketed predicate device(K134032).
3