SPECTRA PULSED DIODE LASER, MODEL DR-1

K032846 · Spectragenics, Inc. · GEX · Dec 11, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032846
• Device Name: SPECTRA PULSED DIODE LASER, MODEL DR-1
• Applicant: Spectragenics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spectra Hair Removal Laser is intended to effect temporary hair removal.

Device Story

Spectra Hair Removal Laser is a semiconductor diode laser system emitting infrared light at a nominal 800 nm wavelength. Device is used for temporary hair removal. Operation involves delivery of laser energy to target areas. Device is intended for use by healthcare professionals in clinical settings. Output consists of pulsed laser light; clinical effect is achieved through photothermolysis of hair follicles. Benefit to patient is temporary reduction of unwanted hair.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the device's technological characteristics and indications for use being a subset of those cleared for the identified predicate devices; bench testing was not required for this submission.

Technological Characteristics

Semiconductor diode laser system; 800 nm nominal wavelength; infrared light output. Device is a powered surgical laser instrument (Product Code GEX).

Indications for Use

Indicated for temporary hair removal in patients seeking cosmetic hair reduction.

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

• LightSheer (StarLight) pulsed diode laser (K973324, K982940, K001746)
• SLP 1000 (LC 100) pulsed diode laser (K010580, K011747)
• Apex 800 pulsed diode laser (K020849)
• F1 pulsed diode laser (K030235)

Submission Summary (Full Text)

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DEC 1 1 2003

K 032846 1/2

## Appendix A. 510(k) Summary

This 510(k) Summary of Safety and Effectiveness for the Spectra Hair Removal Laser is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, and follows the HHS Publication FDA 95-4158 concerning the content and organization of a 510(k) summary.

| Applicant | SpectraGenics, Inc., |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 7083 Commerce Circle, Ste. I<br>Pleasanton, CA 94588 |
| Contact person: | Robert E. Grove, Ph.D. |
| Telephone: | [phone] |
| Preparation date: | September 10, 2003 |
| Device Trade Name: | Spectra Hair Removal Laser |
| Common Name: | Pulsed diode laser |
| Classification Name: | Laser Instrument, Surgical, Powered<br>(Laser surgical instrument for use in<br>general and plastic surgery and<br>dermatology)<br>Regulation No. 878.4810<br>Product Code: GEX; Panel: 79 |
| Legally Marketed Predicate Devices: | LightSheer (StarLight) pulsed diode<br>laser<br>Star Medical / Coherent Star<br>K973324, K982940, K001746 |
| | SLP 1000 (LC 100) pulsed diode laser<br>Palomar Medical Technologies<br>K010580, K011747 |
| | Apex 800 pulsed diode laser<br>IRIDEX Corporation<br>K020849 |
| | F1 pulsed diode laser<br>Opus Medical, Inc.<br>K030235 |

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## K032846 2/2

| System Description: | The Spectra Hair Removal Laser is a<br>semiconductor diode laser system that<br>delivers infrared light at a wavelength of<br>nominally 800 nm. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of the Device: | The Spectra Hair Removal Laser is<br>intended to effect temporary hair removal. |
| Performance Data: | None. The specifications and indications<br>for use of the Spectra Hair Removal Laser<br>are a subset of those claimed in one or more<br>of the clearances for the above-listed<br>predicate devices. Thus performance data<br>were not required. |
| Conclusion: | The Spectra Hair Removal Laser is<br>substantially equivalent to the legally-<br>marketed claimed predicate devices for the<br>purposes of this 510(k) submission. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three stripes forming its wings. The eagle is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2003

Robert E. Grove, Ph.D. President and CEO SpectraGenics, Inc. 7083 Commerce Circle, Suite I Pleasanton, California 94588

Re: K032846 Trade/Device Name: Spectra Hair Removal Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 5, 2003 Received: September 15, 2003

Dear Dr. Grove:

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 the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Robert E. Grove, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witton, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K032846

Device Name: Spectra Hair Removal Laser

Indications for Use: Temporary hair removal

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over the Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

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