SPECTRA HAIR REMOVAL LASER

K052848 · Spectragenics, Inc. · GEX · Dec 27, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052848
• Device Name: SPECTRA HAIR REMOVAL LASER
• Applicant: Spectragenics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 27, 2005
• 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 for temporary hair removal.

Device Story

The Spectra Hair Removal Laser is a semiconductor diode laser system emitting infrared light at a nominal wavelength of 800 nm. It is designed for temporary hair removal. The device functions by delivering pulsed laser energy to the skin to target hair follicles. It is intended for use by trained professionals in a clinical or dermatological setting. The healthcare provider operates the device to deliver energy to the treatment area; the output affects hair growth cycles to achieve temporary removal. The device benefits patients by providing a non-invasive method for hair reduction.

Clinical Evidence

No clinical data. Bench testing only; substantial equivalence was determined based on comparison of specifications and indications for use to legally marketed predicate devices.

Technological Characteristics

Semiconductor diode laser system; 800 nm wavelength; pulsed energy delivery. Class II device (21 CFR 878.4810).

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

• Spectra Hair Removal Laser (K032846)
• LightSheer (StarLight) pulsed diode laser (K973324, K982940, K001746)
• SLP 1000 (LC 100) pulsed diode laser (K010580, K011747)
• Apex 800 pulsed diode laser (K020849)
• F-1 pulsed diode laser (K030235)

Submission Summary (Full Text)

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K052848

## 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness for the Spectra Hair Removal Laser is
1000 This STO(K) Sunmary of Safety and Eironerers of the Safe Medical Devices Act of 1990, submitted in accordance with the requires of 1992, and follows the HHS Publication FDA 95the Medical Dortyee content and organization of a 510(k) summary.

| Applicant: | SpectraGenics, Inc., |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 5880 W. Las Positas Blvd., Suite 52<br>Pleasanton, CA 94588-8552 |
| Contact person: | Robert E. Grove, Ph.D. |
| Telephone: | [phone] |
| Preparation date: | October 5, 2005 |
| 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: | Spectra Hair Removal Laser<br>SpectraGenics, Inc.<br>K032846 |
| | LightSheer (StarLight) pulsed diode laser<br>Star Medical / Coherent Star<br>K973324, K982940, K001746 |
| | SLP 1000 (LC 100) pulsed diode laser<br>Palomar Medical Technologies, Inc.<br>K010580, K011747 |
| | Apex 800 pulsed diode laser<br>Iridex Corporation<br>K020849 |

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| | F-1 pulsed diode laser<br>Opusmed, Inc.<br>K030235 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 intended<br>for temporary hair removal. |
| Performance Data: | None. The specifications and indications for<br>use of the Spectra Hair Removal Laser are<br>substantially equivalent to those claimed in<br>the clearance for the above-listed predicate<br>devices. Thus performance data were not<br>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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 2 7 2005

Mr. Robert E. Grove, Ph.D. President & CEO Spectragenics, Inc. 5880 West Las Positas Blvd., Suite 52 Pleasanton, California 94588

Re: K052848

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: October 5, 2005 Received: October 12, 2005

Dear Dr. Grove:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section 510(x) prematice insubstantially equivalent (for the indications referenced above and nave ucterimined the acress as edicate devices marketed in interstate for use stated in the encrosule) to regally mancede producal Device Americal Device Ameradments, or to commerce prior to May 28, 1770, the chasinon and ever sions of the Federal Food, Drug, devices that have been recarsined in accordance will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previoione of the Act and Cosmetic Act (Act) that do not require upproval of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general contr You may, therefore, market the device, subject to general registration, listing of
general controls provisions of the Act include requirements for annual registration and general controls provisions of the rectments requirements of and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (See above) into entile chass regulations affecting your device
it may be subject to such additional controls. Existing major regulations all t it may be subject to such additional controls: "Zholing may be of the 200 to 898. In addition, FDA can be found in the Code of Federal regerming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that I DA s Issuality of a succeannal requirements of the Act
that FDA has made a determination that your device complies with other must that I'DA has made a delemination mac Jour as roo by other Federal agencies. You must
or any Federal statutes and regulations administered by other Federal agencies. You ma or any Federal Statures and regulations administered of registration and listing (21 comply with an the Act 3 requirements, news 801); good manufacturing practice requirements as settem CFK Part 807); labeling (21 CFR Part 801); good manart 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 GFR 1900 form in the quality systems (Q5) regulantin (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. Grove

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the p premarket notification. "The I DA miding of Justication 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 If you desire specific advice for your accessor and the regulation entitled, the regulation entitled, Contact the Office of Compulation at [phone] Part 807.97). You may obtain "Misbranding by relerence to premarket noutheation" (2) of from the Division of Small other general Information on your responsion.com at its toll-free number [phone] or 1 Manufacturers, International and Consumer Problement of arch/industry/support/index.html.

Sincerely yours,

Barbara Buehrle

Mark N. Melkerson Acting 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):

Device Name:

Spectra Hair Removal Laser

Indications For Use:

The Spectra Hair Removal Laser is intended for temporary hair removal.

Prescription Use _ レ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Starlane Buckup for mmy

Division of General, Restorative. and Neurological Devices

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