CYNOSURE PHOTOGENICA SPIR

K994437 · Cynosure, Inc. · GEX · Jan 18, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K994437
• Device Name: CYNOSURE PHOTOGENICA SPIR
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cynosure PhotoGenica SPIR laser is indicated for coagulation of dermatological vascular lesions.

Device Story

PhotoGenica SPIR is a solid-state pulsed laser system using an alexandrite crystal as the lasing medium. It emits an invisible 755nm wavelength. The device features a non-contact handpiece and is activated via finger switch or footswitch. It is a floor-standing unit weighing 285 lbs, measuring 44"x19"x24". Operated by clinicians in a dermatological setting, the laser energy is applied to cutaneous vascular lesions to achieve coagulation. The device is intended to provide a therapeutic benefit by treating vascular skin conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid-state pulsed laser; alexandrite crystal lasing medium; 755nm wavelength; non-contact handpiece; 220 VAC, 30A, 50-60 Hz power requirement; dimensions 44"x19"x24"; weight 285 lbs; manual activation via finger or footswitch.

Indications for Use

Indicated for coagulation of dermatological vascular lesions in patients requiring dermatological laser treatment.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Cynosure PhotoGenica LPIR
• Cynosure Apogee Laser

Submission Summary (Full Text)

{0}------------------------------------------------

JAN 18 2000

## K994437

## 510(K) Summary

| Submitter: | Cynosure, Inc.<br>10 Elizabeth Drive<br>Chelmsford, MA 01824 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | December 29, 1999 |
| Device Trade Name: | PhotoGenica SPIR |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device: | Cynosure PhotoGenica LPIR |
| Device Description: | The PhotoGenica SPIR is a solid state laser, having the alexandrite<br>crystal as the lasing medium. It is a pulsed laser with an invisible<br>wavelength of 755nm and a non-contact handpiece. |
| | Laser activation is both by finger switch and footswitch. Overall<br>weight of the laser is 285lbs, and the size is 44"x 19"x24" (HxWxD). |
| | Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase. |
| Intended Use: | The PhotoGenica SPIR is indicated for use in dermatology,<br>specifically cutaneous vascular lesions. |
| Comparison: | The PhotoGenica SPIR Laser is substantially equivalent to the<br>Cynosure Apogee Laser. They are both solid state near infra-red lasers<br>using alexandrite crystal as their lasing medium. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica SPIR Laser is another safe and effective device for<br>dermatologic applications. |
| Additional Information: | None |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a person with outstretched arms, representing health and well-being. The logo is simple and recognizable, conveying the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 18 2000

Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824

K994437 Re:

> Trade Name: Cynosure PhotoGenica SPIR Regulatory Class: II Product Code: GEX Dated: December 29, 1999 Received: December 30,1999

Dear Mr. Cho:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls 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 misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

{2}------------------------------------------------

Page 2 - Mr. George Cho

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Styptn Rluvels

E. Dillard III James Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known): _ K 99 44 37

Device Name: _ Cynosure PhotoGenica SPIR

Indications For Use:

The Cynosure PhotoGenica SPIR laser is indicated for coagulation of dermatological vascular lesions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hugh Rhodes

(Division Sign-Off) Division of General Restorative Devices <994437 510(k) Number

Prescription Use 0 (Per 21 CFR 801.109)

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)