SPECTRA HAIR REMOVAL LASER

K053527 · Spectragenics, Inc. · GEX · Feb 1, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K053527
• Device Name: SPECTRA HAIR REMOVAL LASER
• Applicant: Spectragenics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spectra Hair Removal Laser System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

Device Story

The Spectra Hair Removal Laser System is an over-the-counter device for home-use hair removal. It consists of a semiconductor diode laser emitting infrared light at 800 nm and a skin sensor. The skin sensor evaluates the user's skin to determine if the laser can be safely operated. The device is used as an adjunct to shaving, requiring periodic treatments to sustain hair removal. The system provides a mechanism for consumers to perform hair removal outside of a clinical setting.

Clinical Evidence

Clinical data was provided to support the safety and efficacy of the device in a simulated home-use environment. The study was conducted to support the over-the-counter clearance, demonstrating that the device is safe and effective for its intended use when operated by non-professionals.

Technological Characteristics

Semiconductor diode laser system; 800 nm infrared wavelength; includes integrated skin sensor for safety assessment; over-the-counter home-use form factor.

Indications for Use

Indicated for hair removal in an over-the-counter, home-use setting as an adjunct to shaving.

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, K052848)
• LightSheer (StarLight) pulsed diode laser (K973324, K982940, K001746)
• SLP 1000 (LC 100) pulsed diode laser (K013028, K010580, K011747)
• Apex 800 pulsed diode laser (K020849)

Reference Devices

• F-1 pulsed diode laser (K030235)
• SpaTouch PhotoEpilation System (K020856)
• SpaTouch Pro PhotoEpilation System (K020856)
• SkinTouch (K030897, K051671)
• ABC Hair Removal System (K060839)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

KOS 3527

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: | 5880 W. Las Positas Blvd., Suite 52<br>Pleasanton, CA 94588-8552 | |
| Contact person: | Robert E. Grove, Ph.D. | |
| Telephone: | [phone] | FEB - 1 2007 |
| Preparation date: | December 3, 2007 | |
| Device Trade Name: | Spectra Hair Removal Laser System | |
| 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, K052848<br><br>LightSheer (StarLight) pulsed diode laser<br>Star Medical / Coherent Star<br>K973324, K982940, K001746<br><br>SLP 1000 (LC 100) pulsed diode laser<br>Palomar Medical Technologies, Inc.<br>K013028, K010580, K011747<br><br>Apex 800 pulsed diode laser<br>Iridex Corporation<br>K020849 | |

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F-1 pulsed diode laser Opusmed, Inc. K030235

SpaTouch® PhotoEpilation System Radiancy (Israel) Ltd. K020856

SpaTouch Pro PhotoEpilation System Radiancy (Israel) Ltd. Presumed to be K020856

SkinTouch Radiancy (Israel) Ltd. K030897, K051671

ABC Hair Removal System Palomar Medical Technologies, Inc. K060839

The Spectra Hair Removal System consists of the Spectra Laser and Spectra Skin Sensor. The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm. The Spectra Skin Sensor determines whether users can safely use the Spectra Hair Removal Laser.

The Spectra Hair Removal Laser System is an overthe-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

The specifications and indications for use of the Spectra Hair Removal Laser System are substantially equivalent to those claimed in the clearance for the above-listed predicate devices.

Clinical data is provided to demonstrate the safety and efficacy of the Spectra Hair Removal Laser System in a simulated home-use environment to support the over-the-counter clearance.

System Description:

Intended Use of the Device:

Performance Data:

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Conclusion:

The Spectra Hair Removal Laser System is substantially equivalent to the legally-marketed
claimed predicate devices for the purposes of this 510(k) submission.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three distinct lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird, with the words separated by dots.

FEB - 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SpectraGenics, Inc. % Robert E. Grove, Ph. D. President & CEO 5880 West Las Positas Boulevard Pleasanton, California 94588

Re: K053527

Trade/Device Name: Spectra Hair Removal Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: August 08, 2007 Received: August 13, 2007

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. Iisting 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

Mark M. Mullerson

Mark N. Melkerson 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): ___ K053527

Device Name:

Spectra Hair Removal Laser System

Indications For Use:

The Spectra Hair Removal Laser System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

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-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division S gn=(){{ Division of General, Restorative, and Neurological Devices

**510(k) Number** | 1053527