+-----------------------+---+------+---+----------+----+---+--------------+
| **DEPARTMENT OF       |   | *    |   |          |    | F |              |
| HEALTH AND HUMAN      |   | *APP |   |          |    | o |              |
| SERVICES**\           |   | LICA |   |          |    | r |              |
| Food and Drug         |   | TION |   |          |    | m |              |
| Administration        |   | FOR  |   |          |    | A |              |
|                       |   | A    |   |          |    | p |              |
|                       |   | VARI |   |          |    | p |              |
|                       |   | ANCE |   |          |    | r |              |
|                       |   | FROM |   |          |    | o |              |
|                       |   | 21   |   |          |    | v |              |
|                       |   | CFR  |   |          |    | e |              |
|                       |   | 10   |   |          |    | d |              |
|                       |   | 40.1 |   |          |    | : |              |
|                       |   | 1(c) |   |          |    | O |              |
|                       |   | FOR  |   |          |    | M |              |
|                       |   | A    |   |          |    | B |              |
|                       |   | L    |   |          |    | N |              |
|                       |   | ASER |   |          |    | o |              |
|                       |   | L    |   |          |    | . |              |
|                       |   | IGHT |   |          |    | 0 |              |
|                       |   | S    |   |          |    | 9 |              |
|                       |   | HOW, |   |          |    | 1 |              |
|                       |   | D    |   |          |    | 0 |              |
|                       |   | ISPL |   |          |    | - |              |
|                       |   | AY,\ |   |          |    | 0 |              |
|                       |   | OR   |   |          |    | 0 |              |
|                       |   | DEVI |   |          |    | 2 |              |
|                       |   | CE** |   |          |    | 5 |              |
|                       |   |      |   |          |    | E |              |
|                       |   |      |   |          |    | x |              |
|                       |   |      |   |          |    | p |              |
|                       |   |      |   |          |    | i |              |
|                       |   |      |   |          |    | r |              |
|                       |   |      |   |          |    | a |              |
|                       |   |      |   |          |    | t |              |
|                       |   |      |   |          |    | i |              |
|                       |   |      |   |          |    | o |              |
|                       |   |      |   |          |    | n |              |
|                       |   |      |   |          |    | D |              |
|                       |   |      |   |          |    | a |              |
|                       |   |      |   |          |    | t |              |
|                       |   |      |   |          |    | e |              |
|                       |   |      |   |          |    | : |              |
|                       |   |      |   |          |    | D |              |
|                       |   |      |   |          |    | e |              |
|                       |   |      |   |          |    | c |              |
|                       |   |      |   |          |    | e |              |
|                       |   |      |   |          |    | m |              |
|                       |   |      |   |          |    | b |              |
|                       |   |      |   |          |    | e |              |
|                       |   |      |   |          |    | r |              |
|                       |   |      |   |          |    | 3 |              |
|                       |   |      |   |          |    | 1 |              |
|                       |   |      |   |          |    | , |              |
|                       |   |      |   |          |    | 2 |              |
|                       |   |      |   |          |    | 0 |              |
|                       |   |      |   |          |    | 0 |              |
|                       |   |      |   |          |    | 6 |              |
|                       |   |      |   |          |    | S |              |
|                       |   |      |   |          |    | e |              |
|                       |   |      |   |          |    | e |              |
|                       |   |      |   |          |    | P |              |
|                       |   |      |   |          |    | a |              |
|                       |   |      |   |          |    | g |              |
|                       |   |      |   |          |    | e |              |
|                       |   |      |   |          |    | 4 |              |
|                       |   |      |   |          |    | f |              |
|                       |   |      |   |          |    | o |              |
|                       |   |      |   |          |    | r |              |
|                       |   |      |   |          |    | O |              |
|                       |   |      |   |          |    | M |              |
|                       |   |      |   |          |    | B |              |
|                       |   |      |   |          |    | S |              |
|                       |   |      |   |          |    | t |              |
|                       |   |      |   |          |    | a |              |
|                       |   |      |   |          |    | t |              |
|                       |   |      |   |          |    | e |              |
|                       |   |      |   |          |    | m |              |
|                       |   |      |   |          |    | e |              |
|                       |   |      |   |          |    | n |              |
|                       |   |      |   |          |    | t |              |
|                       |   |      |   |          |    | . |              |
+-----------------------+---+------+---+----------+----+---+--------------+
|                       |   |      |   |          |    | D |              |
|                       |   |      |   |          |    | O |              |
|                       |   |      |   |          |    | C |              |
|                       |   |      |   |          |    | K |              |
|                       |   |      |   |          |    | E |              |
|                       |   |      |   |          |    | T |              |
|                       |   |      |   |          |    | N |              |
|                       |   |      |   |          |    | U |              |
|                       |   |      |   |          |    | M |              |
|                       |   |      |   |          |    | B |              |
|                       |   |      |   |          |    | E |              |
|                       |   |      |   |          |    | R |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| **NOTE:** No laser    |   |      |   |          |    |   |              |
| light show,           |   |      |   |          |    |   |              |
| projection system, or |   |      |   |          |    |   |              |
| device may vary from  |   |      |   |          |    |   |              |
| compliance with 21    |   |      |   |          |    |   |              |
| CFR 1040.11(c) in     |   |      |   |          |    |   |              |
| design or use without |   |      |   |          |    |   |              |
| the approval of this  |   |      |   |          |    |   |              |
| application in        |   |      |   |          |    |   |              |
| accordance with 21    |   |      |   |          |    |   |              |
| CFR 1010.4.           |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| **INSTRUCTIONS**      |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
| 1\. Check all         |   |      |   |          |    |   |              |
| applicable boxes and  |   |      |   |          |    |   |              |
| type or print the 3.  |   |      |   |          |    |   |              |
| Mail your application |   |      |   |          |    |   |              |
| to the Dockets        |   |      |   |          |    |   |              |
| Management Branch     |   |      |   |          |    |   |              |
| (HFA-305), Food and   |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
| requested             |   |      |   |          |    |   |              |
| information. Drug     |   |      |   |          |    |   |              |
| Administration, Rm    |   |      |   |          |    |   |              |
| 1061, 5630 Fishers    |   |      |   |          |    |   |              |
| Lane, Rockville, MD   |   |      |   |          |    |   |              |
| 20852.                |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
| 2\. Submit an         |   |      |   |          |    |   |              |
| original and four (4) |   |      |   |          |    |   |              |
| copies. 4. Enter      |   |      |   |          |    |   |              |
| docket number if      |   |      |   |          |    |   |              |
| assigned.             |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| 1\. NAME OF COMPANY   |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
| >                     |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| 2\. ADDRESS OF        |   |      |   |          |    |   |              |
| COMPANY *(Include ZIP |   |      |   |          |    |   |              |
| Code)(If P.O. Box is  |   |      |   |          |    |   |              |
| used, include actual  |   |      |   |          |    |   |              |
| street address        |   |      |   |          |    |   |              |
| also.)*               |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| 3\. NAME AND TITLE OF |   |      | 4 |          |    |   | 5\. DATE OF  |
| RESPONSIBLE PERSON    |   |      | \ |          |    |   | SUBMISSION   |
|                       |   |      | . |          |    |   |              |
|                       |   |      | T |          |    |   | >            |
|                       |   |      | E |          |    |   |              |
|                       |   |      | L |          |    |   |              |
|                       |   |      | E |          |    |   |              |
|                       |   |      | P |          |    |   |              |
|                       |   |      | H |          |    |   |              |
|                       |   |      | O |          |    |   |              |
|                       |   |      | N |          |    |   |              |
|                       |   |      | E |          |    |   |              |
|                       |   |      | N |          |    |   |              |
|                       |   |      | O |          |    |   |              |
|                       |   |      | . |          |    |   |              |
|                       |   |      | * |          |    |   |              |
|                       |   |      | ( |          |    |   |              |
|                       |   |      | I |          |    |   |              |
|                       |   |      | n |          |    |   |              |
|                       |   |      | c |          |    |   |              |
|                       |   |      | l |          |    |   |              |
|                       |   |      | u |          |    |   |              |
|                       |   |      | d |          |    |   |              |
|                       |   |      | e |          |    |   |              |
|                       |   |      | a |          |    |   |              |
|                       |   |      | r |          |    |   |              |
|                       |   |      | e |          |    |   |              |
|                       |   |      | a |          |    |   |              |
|                       |   |      | c |          |    |   |              |
|                       |   |      | o |          |    |   |              |
|                       |   |      | d |          |    |   |              |
|                       |   |      | e |          |    |   |              |
|                       |   |      | ) |          |    |   |              |
|                       |   |      | * |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| 6\. THE APPLICANT     |   |      |   |          |    |   |              |
| REQUESTS THE VARIANCE |   |      |   |          |    |   |              |
| TO BE IN EFFECT FOR A |   |      |   |          |    |   |              |
| PERIOD OF     YEARS   |   |      |   |          |    |   |              |
| FROM THE DATE OF      |   |      |   |          |    |   |              |
| ISSUE.\               |   |      |   |          |    |   |              |
| *(In general, the     |   |      |   |          |    |   |              |
| Agency will approve a |   |      |   |          |    |   |              |
| variance for only two |   |      |   |          |    |   |              |
| years. If a longer    |   |      |   |          |    |   |              |
| period is requested,  |   |      |   |          |    |   |              |
| a justification must  |   |      |   |          |    |   |              |
| be attached as part   |   |      |   |          |    |   |              |
| of the application.)* |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| 7\. **PRODUCT         |   |      |   |          |    |   |              |
| DESCRIPTION AND USE** |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| a\. LIST NAME AND/OR  |   |      |   |          |    |   |              |
| MODEL NUMBER(S) FOR   |   |      |   |          |    |   |              |
| THE LASER LIGHT       |   |      |   |          |    |   |              |
| SHOW(S) AND           |   |      |   |          |    |   |              |
| PROJECTOR(S)          |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| b\. PRODUCT FOR WHICH |   |      |   | f\.      |    |   |              |
| A VARIANCE IS         |   |      |   | PRODUCT  |    |   |              |
| REQUESTED             |   |      |   | IS       |    |   |              |
|                       |   |      |   | INTENDED |    |   |              |
| > A laser display     |   |      |   | TO BE    |    |   |              |
| > device              |   |      |   | USED AT  |    |   |              |
| >                     |   |      |   | ANY ONE  |    |   |              |
| > A projector for a   |   |      |   | LOCATION |    |   |              |
| > laser light show    |   |      |   |          |    |   |              |
| >                     |   |      |   | > More   |    |   |              |
| > A laser light show  |   |      |   | > than   |    |   |              |
| >                     |   |      |   | > 15     |    |   |              |
| > Other *(Specify)*   |   |      |   | > days   |    |   |              |
| >                     |   |      |   | >        |    |   |              |
|                       |   |      |   | > More   |    |   |              |
| c\. PROJECTORS ARE    |   |      |   | > than 5 |    |   |              |
| INTENDED FOR SALE,    |   |      |   | > but    |    |   |              |
| LEASE, OR LOAN TO     |   |      |   | > not    |    |   |              |
| OTHER LASER LIGHT     |   |      |   | > more   |    |   |              |
| SHOW PRODUCERS        |   |      |   | > than   |    |   |              |
|                       |   |      |   | > 15     |    |   |              |
| d\. PRODUCT IS        |   |      |   | > days   |    |   |              |
| INTENDED FOR USE IN A |   |      |   | >        |    |   |              |
|                       |   |      |   | > Less   |    |   |              |
| > Planetarium or      |   |      |   | > than 5 |    |   |              |
| > other dome          |   |      |   | > days   |    |   |              |
| > projection          |   |      |   |          |    |   |              |
| > structure           |   |      |   | g\. TOUR |    |   |              |
| >                     |   |      |   | IS       |    |   |              |
| > Theater             |   |      |   | INTENDED |    |   |              |
| >                     |   |      |   | TO RUN   |    |   |              |
| > Hotel/motel         |   |      |   | FOR      |    |   |              |
| > ballroom or meeting |   |      |   |          |    |   |              |
| > room                |   |      |   | > More   |    |   |              |
| >                     |   |      |   | > than 6 |    |   |              |
| > Store displays      |   |      |   | > months |    |   |              |
| >                     |   |      |   | >        |    |   |              |
| > Trade show or       |   |      |   | > 1-6    |    |   |              |
| > convention          |   |      |   | > months |    |   |              |
| >                     |   |      |   | >        |    |   |              |
| > Discotheque or      |   |      |   | > Less   |    |   |              |
| > night club          |   |      |   | > than   |    |   |              |
| >                     |   |      |   | > one    |    |   |              |
| > Pavilion            |   |      |   | > month  |    |   |              |
| >                     |   |      |   | >        |    |   |              |
| > Indoor arena        |   |      |   | > Not    |    |   |              |
| >                     |   |      |   | > ap     |    |   |              |
| > Outdoor arena       |   |      |   | plicable |    |   |              |
| >                     |   |      |   | > *(Not  |    |   |              |
| > Museum              |   |      |   | > a      |    |   |              |
| >                     |   |      |   | > tour)* |    |   |              |
| > Outdoor unenclosed  |   |      |   | >        |    |   |              |
| > area                |   |      |   | > Other  |    |   |              |
| >                     |   |      |   | > *(S    |    |   |              |
| > Other *(Specify)*   |   |      |   | pecify)* |    |   |              |
| >                     |   |      |   | >        |    |   |              |
|                       |   |      |   |          |    |   |              |
| e\. PRODUCT IS        |   |      |   | h\.      |    |   |              |
| INTENDED TO BE USED   |   |      |   | PRODUCT  |    |   |              |
|                       |   |      |   | UTILIZES |    |   |              |
| > At only one         |   |      |   | THE      |    |   |              |
| > *(Fixed)* location  |   |      |   | F        |    |   |              |
| >                     |   |      |   | OLLOWING |    |   |              |
| > At a variety of     |   |      |   | LASER    |    |   |              |
| > *(Tour)* locations  |   |      |   | EFFECTS  |    |   |              |
| >                     |   |      |   |          |    |   |              |
| > Other *(Specify)*   |   |      |   | > Front  |    |   |              |
| >                     |   |      |   | > screen |    |   |              |
|                       |   |      |   | > pro    |    |   |              |
|                       |   |      |   | jections |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | > Rear   |    |   |              |
|                       |   |      |   | > screen |    |   |              |
|                       |   |      |   | > pro    |    |   |              |
|                       |   |      |   | jections |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | > Hol    |    |   |              |
|                       |   |      |   | ographic |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | displays |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | Multiple |    |   |              |
|                       |   |      |   | > reflec |    |   |              |
|                       |   |      |   | tion/dif |    |   |              |
|                       |   |      |   | fraction |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   |  effects |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | Audience |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | scanning |    |   |              |
|                       |   |      |   | > *(Also |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | includes |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | scanning |    |   |              |
|                       |   |      |   | > any    |    |   |              |
|                       |   |      |   | > ac     |    |   |              |
|                       |   |      |   | cessible |    |   |              |
|                       |   |      |   | > unco   |    |   |              |
|                       |   |      |   | ntrolled |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   |  areas)* |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | > Ref    |    |   |              |
|                       |   |      |   | lections |    |   |              |
|                       |   |      |   | > from   |    |   |              |
|                       |   |      |   | > st     |    |   |              |
|                       |   |      |   | ationary |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   |  mirrors |    |   |              |
|                       |   |      |   | > or     |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | mirrored |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | surfaces |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   |  *(Beam* |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | > *Ma    |    |   |              |
|                       |   |      |   | trices)* |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | > St     |    |   |              |
|                       |   |      |   | ationary |    |   |              |
|                       |   |      |   | > irr    |    |   |              |
|                       |   |      |   | adiation |    |   |              |
|                       |   |      |   | > of     |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | rotating |    |   |              |
|                       |   |      |   | > mirror |    |   |              |
|                       |   |      |   | > balls, |    |   |              |
|                       |   |      |   | > etc.   |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | Scanning |    |   |              |
|                       |   |      |   | > irr    |    |   |              |
|                       |   |      |   | adiation |    |   |              |
|                       |   |      |   | > of     |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | rotating |    |   |              |
|                       |   |      |   | > mirror |    |   |              |
|                       |   |      |   | > balls, |    |   |              |
|                       |   |      |   | > etc.   |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | > Fiber  |    |   |              |
|                       |   |      |   | > optic  |    |   |              |
|                       |   |      |   | > pro    |    |   |              |
|                       |   |      |   | jections |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | > Fog,   |    |   |              |
|                       |   |      |   | > smoke, |    |   |              |
|                       |   |      |   | > or     |    |   |              |
|                       |   |      |   | > other  |    |   |              |
|                       |   |      |   | > sc     |    |   |              |
|                       |   |      |   | attering |    |   |              |
|                       |   |      |   | > enh    |    |   |              |
|                       |   |      |   | ancement |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   |  effects |    |   |              |
|                       |   |      |   | >        |    |   |              |
|                       |   |      |   | > Other  |    |   |              |
|                       |   |      |   | > *(S    |    |   |              |
|                       |   |      |   | pecify)* |    |   |              |
|                       |   |      |   | >        |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| **LASER RADIATION     |   |      |   |          |    |   |              |
| LEVELS**8.            |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| LASER MEDIUM *(Ar,    | W |      |   |          | PE |   |              |
| He-Ne,etc.)*          | A |      |   |          | AK |   |              |
|                       | V |      |   |          | P  |   |              |
|                       | E |      |   |          | OW |   |              |
|                       | L |      |   |          | ER |   |              |
|                       | E |      |   |          | *  |   |              |
|                       | N |      |   |          | (w |   |              |
|                       | G |      |   |          | at |   |              |
|                       | T |      |   |          | ts |   |              |
|                       | H |      |   |          | )* |   |              |
|                       | S |      |   |          |    |   |              |
|                       | * |      |   |          |    |   |              |
|                       | ( |      |   |          |    |   |              |
|                       | n |      |   |          |    |   |              |
|                       | m |      |   |          |    |   |              |
|                       | ) |      |   |          |    |   |              |
|                       | * |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| 9\. IF ANY LASER      |   |      |   |          |    |   |              |
| RADIATION IS PULSED   |   |      |   |          |    |   |              |
| OR SCANNED, GIVE THE  |   |      |   |          |    |   |              |
| PULSE DURATION AND    |   |      |   |          |    |   |              |
| RATE AND SCANNING     |   |      |   |          |    |   |              |
| FREQUENCY AND         |   |      |   |          |    |   |              |
| AMPLITUDE             |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+
| 10\. REASON FOR       |   |      |   |          |    |   |              |
| REQUESTING VARIANCE   |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
| Compliance with the   |   |      |   |          |    |   |              |
| limits of 21 CFR      |   |      |   |          |    |   |              |
| 1040.11(c) would      |   |      |   |          |    |   |              |
| restrict the intended |   |      |   |          |    |   |              |
| use of the product    |   |      |   |          |    |   |              |
| because compliance    |   |      |   |          |    |   |              |
| would limit the       |   |      |   |          |    |   |              |
| output power to the   |   |      |   |          |    |   |              |
| extent that the       |   |      |   |          |    |   |              |
| desired effects would |   |      |   |          |    |   |              |
| not be sufficiently   |   |      |   |          |    |   |              |
| visible               |   |      |   |          |    |   |              |
|                       |   |      |   |          |    |   |              |
| Other or additional   |   |      |   |          |    |   |              |
| explanation           |   |      |   |          |    |   |              |
| *(Specify)*           |   |      |   |          |    |   |              |
+-----------------------+---+------+---+----------+----+---+--------------+

+-----------------------------------------------------------------------+
| 11\. MANNER IN WHICH IT IS PROPOSED TO DEVIATE FROM THE REQUIREMENTS  |
| OF THE APPLICABLE STANDARD                                            |
|                                                                       |
| > It is proposed to deviate from the provisions of 21 CFR 1040.11(c)  |
| > in that the accessible emission level would exceed the\             |
| > accessible emission limits specified in 21 CFR 1040.11(c).          |
| >                                                                     |
| > It is proposed to deviate from the provisions of 21 CFR 1040.11(c)  |
| > as follows:                                                         |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| 12\. ADVANTAGES TO BE DERIVED FROM SUCH DEVIATION                     |
|                                                                       |
| > Laser light shows and displays are accepted popular media in        |
| > entertainment and the arts. Use of power levels in excess\          |
| > of the limits imposed by 21 CFR 1040.11(c) is necessary to achieve  |
| > the required effects in these media.                                |
| >                                                                     |
| > Other or additional advantages *(describe and explain)*             |
+-----------------------------------------------------------------------+
| 13\. EXPLAIN THE ALTERNATE MEANS OF RADIATION PROTECTION TO BE        |
| PROVIDED. *(Check as many boxes as apply. In item 14 \"Remarks,\"\    |
| justify any boxes not checked, using additional sheets as necessary.  |
| State any other means of radiation protection that will be used.)*    |
|                                                                       |
| a\. All laser products, systems, shows, and projectors will be        |
| certified to comply with 21 CFR 1040.10 and the conditions of this    |
| variance and will be reported as required by 21 CFR 1002.10 AND       |
| 1002.11 using the reporting guides provided for such purpose. These   |
| actions will be accomplished prior to any introduction into commerce. |
|                                                                       |
| b\. Effects not specifically indicated in this variance application   |
| will not be performed. No other effects will be added until an        |
| amendment to the variance has been obtained and the required reports  |
| or supplements, as applicable, have been submitted.                   |
|                                                                       |
| c\. Scanning, projection, or reflection of laser and collateral       |
| radiation *(Light show radiation)* into audience or other accessible  |
| uncontrolled areas will not be permitted except for diffuse           |
| reflections produced by the atmosphere, added atmospheric scattering  |
| media, and target screens.                                            |
|                                                                       |
| d\. Laser radiation levels in excess of the limits of Class I will    |
| not be permitted at any point less than 3.0 meters above any surface  |
| upon which persons other than operators, performers, or employees are |
| permitted to stand or 2.5 meters below or in lateral separation from  |
| any place where such persons are permitted to be. Operators,          |
| performers, and employees will not be required or allowed to view     |
| radiation above the limits of Class I or be exposed to radiation      |
| above the limits specified in 21 CFR 1040.11(c).                      |
|                                                                       |
| e\. Any product which relies on scanning to meet access, exposure, or |
| product class limits will incorporate a scanning safeguard system     |
| which directly senses scanner motion and which will react fast enough |
| to preclude exceeding the applicable limit.                           |
|                                                                       |
| f\. All laser light shows shall be under the direct and personal      |
| control of trained, competent operator(s). The operator(s) will:      |
|                                                                       |
| \(1\) Be an employee of the variance holder who will be responsible   |
| for the training and the conduct of the operator;                     |
|                                                                       |
| \(2\) Be located where all beam paths can be directly observed at all |
| times; and                                                            |
|                                                                       |
| \(3\) Immediately terminate the emission of light show radiation in   |
| the event of any unsafe condition; or, for outdoor shows, upon        |
| request by any air traffic control officials.                         |
|                                                                       |
| g\. The maximum laser projector output power will not exceed the      |
| level required to obtain the intended effects.                        |
|                                                                       |
| h\. The projection system *(i.e., the projector and all other         |
| components used to produce the lighting effects)* will be securely    |
| mounted or immobilized to prevent unintended movement or              |
| misalignment. Beam masking will be provided as an inherent part of    |
| the system design to prevent overfilling of screens, beam stops,      |
| targets, etc.                                                         |
|                                                                       |
| I Laser projectors will not be delivered to any other party under an  |
| agreement of sale, lease, or loan unless and until the recipient      |
| demonstrates that they have a variance in effect at the time of       |
| delivery that permits them to produce laser light shows incorporating |
| such projector(s).                                                    |
|                                                                       |
| J In addition to the requirements of 21 CFR 1040.10(h), the           |
| manufacturer of laser projectors/systems will provide to parties who  |
| purchase, lease, or borrow the equipment, adequate users'             |
| instructions for safe installation and operation which explain the    |
| responsibility of the recipient as an independent light show          |
| manufacturer to submit the required reports and apply for and obtain  |
| a variance from CDRH prior to introduction into commerce of any laser |
| light shows.                                                          |
|                                                                       |
| k\. The requirements of 21 CFR 1002.30(a)(1) and (2) will be          |
| accomplished through the use of written procedures for setup,         |
| alignment, testing, and performance of each show. These procedures    |
| will be in sufficient detail to ensure compliance with 21 CFR         |
| 1040.10, the conditions of this variance, and the control of access   |
| to radiation areas using the procedures described in the ANSIZ136.1   |
| standard for the safe use of lasers *(American National Standards     |
| Institute, 1430 Broadway, New York, NY 10018)* or any other           |
| equivalent user consensus standard and, where applicable, state or    |
| local requirements. Laser radiation areas which can contain radiation |
| levels above the limits specified in 21 CFR 1040.11(c) will be        |
| clearly identified by the posting of warning signs and/or restricting |
| access through physical means *(such as pressure switches, photo      |
| cells, barriers, guards, etc.)*. These requirements apply to          |
| temporary areas *(such as during set up and alignment procedures)*    |
| and to final or permanent areas. The variance holder will retain the  |
| records of these procedures and the results of all tests as required  |
| by 21 CFR 1002.31. A copy of the variance application, the approval   |
| letter, current procedures, and records relating to each particular   |
| show will be with the operator or other responsible individual and    |
| will be made available for inspection by FDA and other responsible    |
| authorities.                                                          |
+-----------------------------------------------------------------------+

+-----------------------+----------------------+----------------------+
| > l\. Advance written |                      |                      |
| > notification will   |                      |                      |
| > be made as early as |                      |                      |
| > possible to         |                      |                      |
| > appropriate         |                      |                      |
| > federal, state, and |                      |                      |
| > local authorities   |                      |                      |
| > providing show      |                      |                      |
| > itinerary with      |                      |                      |
| > dates and locations |                      |                      |
| > clearly and         |                      |                      |
| > completely          |                      |                      |
| > identified, and a   |                      |                      |
| > basic description   |                      |                      |
| > of the proposed     |                      |                      |
| > effects including a |                      |                      |
| > statement of the    |                      |                      |
| > maximum power       |                      |                      |
| > output intended.    |                      |                      |
| > Such notifications  |                      |                      |
| > will be made, but   |                      |                      |
| > not necessarily be  |                      |                      |
| > limited, to:        |                      |                      |
| >                     |                      |                      |
| > \(1\) The Center    |                      |                      |
| > for Devices and     |                      |                      |
| > Radiological        |                      |                      |
| > Health, Office of   |                      |                      |
| > Compliance          |                      |                      |
| > (HFZ-342), 2098     |                      |                      |
| > Gaither Road,       |                      |                      |
| > Rockville, MD       |                      |                      |
| > 20850, providing    |                      |                      |
| > the initial and     |                      |                      |
| > closing dates for   |                      |                      |
| > fixed installations |                      |                      |
| > and the itinerary   |                      |                      |
| > for mobile shows.   |                      |                      |
| > In addition, unless |                      |                      |
| > all aspects of each |                      |                      |
| > show have been      |                      |                      |
| > reported and        |                      |                      |
| > accession numbers   |                      |                      |
| > clearly referenced, |                      |                      |
| > each notice will    |                      |                      |
| > include detailed    |                      |                      |
| > descriptions of     |                      |                      |
| > each show and a     |                      |                      |
| > listing of all      |                      |                      |
| > effects to be       |                      |                      |
| > performed in        |                      |                      |
| > sufficient detail   |                      |                      |
| > to confirm          |                      |                      |
| > compliance with the |                      |                      |
| > regulations and     |                      |                      |
| > this variance.      |                      |                      |
| >                     |                      |                      |
| > \(2\) The Federal   |                      |                      |
| > Aviation            |                      |                      |
| > Administration      |                      |                      |
| > (FAA) for any       |                      |                      |
| > projections into    |                      |                      |
| > open airspace at    |                      |                      |
| > any time *(i.e.,    |                      |                      |
| > including setup,    |                      |                      |
| > alignment,          |                      |                      |
| > rehearsals,         |                      |                      |
| > performances,       |                      |                      |
| > etc.)*. If the FAA  |                      |                      |
| > objects to any      |                      |                      |
| > laser effects, the  |                      |                      |
| > objections will be  |                      |                      |
| > resolved and any    |                      |                      |
| > conditions          |                      |                      |
| > requested by FAA    |                      |                      |
| > will be adhered to. |                      |                      |
| > If these conditions |                      |                      |
| > cannot be met, the  |                      |                      |
| > objectionable       |                      |                      |
| > effects will be     |                      |                      |
| > deleted from the    |                      |                      |
| > show                |                      |                      |
| >                     |                      |                      |
| > \(3\) State and     |                      |                      |
| > local radiation     |                      |                      |
| > control             |                      |                      |
| > offices/agencies    |                      |                      |
| > for all shows to be |                      |                      |
| > performed within    |                      |                      |
| > their               |                      |                      |
| > jurisdictions. All  |                      |                      |
| > requirements of     |                      |                      |
| > state and local law |                      |                      |
| > will be satisfied   |                      |                      |
| > and any objections  |                      |                      |
| > raised by local     |                      |                      |
| > authorities will be |                      |                      |
| > resolved or the     |                      |                      |
| > effects deleted.    |                      |                      |
| > *(A list of federal |                      |                      |
| > and state offices   |                      |                      |
| > is available from   |                      |                      |
| > the Center for      |                      |                      |
| > Devices and         |                      |                      |
| > Radiological Health |                      |                      |
| > upon request.)*     |                      |                      |
+-----------------------+----------------------+----------------------+
| 14\. REMARKS          |                      |                      |
|                       |                      |                      |
| >                     |                      |                      |
+-----------------------+----------------------+----------------------+
| **CERTIFICATION**     |                      |                      |
+-----------------------+----------------------+----------------------+
| I CERTIFY that all of |                      |                      |
| the above information |                      |                      |
| and statements are    |                      |                      |
| true, complete, and   |                      |                      |
| correct to the best   |                      |                      |
| of my knowledge and   |                      |                      |
| acknowledge that my   |                      |                      |
| variance application  |                      |                      |
| may be denied or my   |                      |                      |
| variance may be       |                      |                      |
| revoked if this       |                      |                      |
| application is found  |                      |                      |
| to be false,          |                      |                      |
| misleading or         |                      |                      |
| incorrect in any      |                      |                      |
| material way. I have  |                      |                      |
| submitted and will    |                      |                      |
| submit all reports    |                      |                      |
| required by 21 CFR    |                      |                      |
| 1002.10 and 1002.11   |                      |                      |
| on the laser          |                      |                      |
| equipment and         |                      |                      |
| show(s). I further    |                      |                      |
| understand that I may |                      |                      |
| be required by        |                      |                      |
| regulation or by the  |                      |                      |
| Director, Center for  |                      |                      |
| Devices and           |                      |                      |
| Radiological Health,  |                      |                      |
| to supply such other  |                      |                      |
| information as may be |                      |                      |
| necessary to evaluate |                      |                      |
| and act on this       |                      |                      |
| application.          |                      |                      |
+-----------------------+----------------------+----------------------+
| 15\. SIGNATURE        | 16\. NAME *(Type or  | 17\. TITLE           |
|                       | Print)*              |                      |
|                       |                      | >                    |
|                       | >                    |                      |
+-----------------------+----------------------+----------------------+

**Public reporting burden for this collection of information** is
estimated to average .5 hours per response, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing reviewing the collection of
information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for
reducing this burden to:

> Food and Drug Administration
>
> CDRH (HFZ-342)
>
> 2094 Gaither Road
>
> Rockville, MD 20850

*An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
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