LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM

K982940 · Star Medical Technologies, Inc. · GEX · Apr 8, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K982940
• Device Name: LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
• Applicant: Star Medical Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LightSheer™ is intended to effect temporary hair reduction. The LightSheer® is also intended to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

Device Story

LightSheer™ Pulsed Diode Array Laser delivers 800 nm infrared laser light to target melanin in hair follicles. Device features handpiece with diode laser array and water-cooled tip for active skin cooling. Parameters include 5-30 ms pulse duration, 8-32 J pulse energy, and 10-40 J/cm2 fluence at 1 Hz repetition frequency. Operated by clinicians in dermatology or surgical settings. Laser energy absorption in melanin causes thermal damage to hair follicles, resulting in long-term stable hair reduction. Clinical benefit is permanent hair reduction.

Clinical Evidence

Clinical study observed hair and skin responses at 1, 3, 6, 9, and 12 months post-treatment. Results showed no scarring or permanent skin injury, demonstrating safety and effectiveness for permanent hair reduction.

Technological Characteristics

800 nm pulsed diode laser; 9 x 9 mm handpiece tip; water-cooled active skin cooling; 5-30 ms pulse duration; 8-32 J pulse energy; 10-40 J/cm2 fluence; 1 Hz max repetition frequency.

Indications for Use

Indicated for temporary or permanent hair reduction via selective targeting of melanin in hair follicles.

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™ Pulsed Diode Array Laser (K973324)

Submission Summary (Full Text)

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4/SICCI

K982940

## Attachment 4

510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness for the LightSheer™ Pulsed Diode Array Laser is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.

| Applicant: | Star Medical Technologies, Inc.<br>Robert E. Grove, Ph.D., President |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1249 Quarry Lane<br>Pleasanton, CA |
| Contact Person: | Marcy Moore<br>Manager of Clinical Studies |
| Telephone: | 919-676-7166 |
| Fax: | 919-676-3683 |
| Preparation Date: | August 17, 1998 |
| Device Trade Name: | LightSheer™ Pulsed Diode Array Laser |
| Common Name: | LightSheer™ Diode Laser System |
| Classification Name: | Laser surgical instrument for use in General and<br>Plastic Surgery and in Dermatology<br>(see: 21 CFR 878-4810).<br>Product Code: GEX<br>Panel: 79 |
| Legally-Marketed Predicate Device: | LightSheer™ Pulsed Diode Array Laser<br>Star Medical Technologies, Inc.<br>k973324 |
| System Description: | The LightSheer™ delivers pulsed infrared laser light<br>with a wavelength of 800 nm, a selectable pulse<br>duration of 5 - 30 ms, and a selectable pulse energy<br>of 8 - 32 J. The corresponding fluence delivered<br>through the 9 x 9 mm handpiece tip is 10 - 40 J/cm2.<br>The laser pulses are generated at a maximum pulse<br>repetition frequency of 1 Hz by an array of diode |
| | lasers located in the handpiece. The handpiece tip is<br>water-cooled to provide active skin cooling. |
| Intended Use of the Device: | The LightSheer™ is intended to effect temporary<br>hair reduction. The LightSheer® is also intended to<br>effect stable long-term, or permanent, hair reduction<br>through selective targeting of melanin in hair<br>follicles. Permanent hair reduction is defined as a<br>long-term stable reduction in the number of hairs<br>regrowing after a treatment regime. |
| Performance Data: | There are no technological differences. |
| Results of Clinical Study: | Observations of hair and skin responses were<br>recorded prior to treatment and at 1, 3, 6, 9, and 12<br>months after treatment. There was no scarring or<br>permanent skin injury in any subject. The study<br>demonstrated that LightSheer™ is a safe and<br>effective tool for permanent hair reduction. |
| Conclusion: | Based on the foregoing, the LightSheer™ is effective<br>for producing a long-term stable, permanent<br>reduction of hair. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 8 1099

Star Medical Technologies, Inc c/o Ms. Marcy Moore Manager of Clinical Studies 9516 Candor Oaks Drive Raleigh, North Carolina 27615

K982940 Re:

Trade Name: LightSheer™ Pulsed Diode Array Laser System Regulatory Class: II Product Code: GEX Dated: February 1, 1999 Received: February 3, 1999

Dear Ms. Moore:

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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.

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Page 2 - Ms. Marcy Moore

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 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,

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

Enclosure

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## INDICATION FOR USE STATEMENT

510(k) Number: _ 上 982940 ______________________________________________________________________________________________________________________________________________________________________________

Device Name: LightSheer™ Pulsed Diode Array Laser

Indications for Use:

The LightSheer™ is intended to effect temporary hair reduction. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K982940 |

| Prescription Use (per 21 CFR 801.109) | X | OR | Over-the-Counter Use |
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