STARLIGHT PULSED DIODE ARRAY LASER SYSTEM

K973324 · Star Medical Technologies, Inc. · GEX · Dec 3, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973324
• Device Name: STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
• Applicant: Star Medical Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StarLight™ Pulsed Diode Array Laser System is intended to remove hair in Dermatology and Plastic Surgery procedures.

Device Story

StarLight™ Pulsed Diode Array Laser System delivers 800 nm infrared laser light for hair removal. System comprises console, footswitch, and water-cooled handpiece. Physician operates device by pressing handpiece against patient skin and triggering pulse via footswitch/handpiece trigger. Console touch-screen interface allows parameter selection (pulse duration 5-30 ms; energy 8-32 J; fluence 10-40 J/cm²). Device uses diode array to generate pulses at max 1 Hz. Active skin cooling via handpiece tip enhances safety. Clinical benefit includes significant hair loss and prolonged growth delay without scarring or permanent depigmentation.

Clinical Evidence

Clinical study conducted to evaluate hair regrowth and skin response. Observations recorded at 1, 3, 6, and 9 months post-treatment. Results showed significant hair loss and prolonged growth delay. No instances of scarring or permanent depigmentation reported.

Technological Characteristics

Pulsed diode array laser; 800 nm wavelength; 5-30 ms pulse duration; 8-32 J pulse energy; 10-40 J/cm² fluence; 9x9 mm handpiece tip; water-cooled handpiece for active skin cooling; touch-screen console interface; computer-controlled parameters.

Indications for Use

Indicated for hair removal in dermatology and plastic surgery procedures. No specific age or gender restrictions provided.

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

• EpiLaser™ Normal Mode Ruby Laser (K963947)

Submission Summary (Full Text)

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K973324

## Attachment VI

DEC - 3 1997

## 510(K) Summary of Safety and Effectiveness

This 510(K) Summary of Safety and Effectiveness for the StarLight™ Pulsed Diode Array This Jro(K) Sunmary of Bace, with the requirements of Safe Medical Device Dasol Bytenin is casinons the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Star Medical Technologies, Inc. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1249 Quarry Lane, Suite 100<br>Pleasanton, CA 94566 |
| Contact Person: | Robert E. Grove, Ph.D. |
| Telephone: | 510-484-2140 |
| Preparation Date: | August 26, 1997 |
| Device Trade Name: | StarLight™ Pulsed Diode Array Laser System |
| Common Name: | Pulsed Diode Array Laser |
| 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: | EpiLaser™ Normal Mode Ruby Laser<br>Spectrum Medical Technologies, Inc.<br>K963947 |
| System Description: | The StarLight™ 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/cm.<br>The laser pulses are generated at a maximum pulse<br>repetition frequency of 1 Hz by an array of diode |
| | The complete system consists of a console, a<br>footswitch, and a handpiece connected to the<br>console with an umbilical. In standard use, the<br>handpiece is pressed against the patient's skin and a<br>light pulse is delivered when the footswitch and<br>handpiece trigger are depressed. The handpiece tip is<br>water-cooled to provide active skin cooling. Laser<br>parameters and other system features are controlled<br>from the touch-screen on top of the console, which<br>provides an interface to the system computer. |
| Intended Use of the Device: | The StarLight™ Pulsed Diode Array Laser System<br>is indicated to remove hair in Dermatology<br>and Plastic Surgery procedures. |
| Performance Data: | Clinical studies were conducted to provide<br>assurance that differences in the specifications of the<br>StarLight™ laser and the predicate device did not<br>result in different performance or raise new<br>questions of safety or efficacy. |
| Results of Clinical Study: | Observations of hair regrowth and skin responses<br>were recorded prior to treatment and at 1, 3, 6, and<br>9 months after treatment. There was no scarring or<br>permanent depigmentation of the skin in any subject.<br>The study demonstrated that the StarLight™ Pulsed<br>Diode Array Laser System is a safe and effective<br>tool for hair removal, resulting in significant hair loss<br>and prolonged growth delay. |
| Conclusion: | Based on the foregoing, the StarLight™ Pulsed<br>Diode Array Laser System is substantially equivalent<br>to the legally-marketed claimed predicate device,<br>i.e., the Spectrum EpiLaser™ for hair removal. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 1997

Star Medical Technologies, Incorporated C/O Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Technologies, Incorporated 9516 Candor Oaks Drive Raleigh, North Carolina 27615

Re: K973324

> Trade Name: StarLight™ Pulse Diode Array Laser System Regulatory Class: II Product Code: GEX Dated: August 28, 1997 Received: September 4, 1997

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 requirements , as set forth in the Quality System Regulation (OS) 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

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Page 2 - Ms. Moore

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 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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## K973324

## INDICATION FOR USE STATEMENT

510(K) Number: Pending________________________________________________________________________________________________________________________________________________________

StarLight™ Pulsed Diode Array Laser System____________________________________________________________________________________________________________________________________ Device Name:

Indications for Use:

The StarLight™ Pulsed Diode Array Laser System is intended to remove hair in Dermatology and Plastic Surgery procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
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Division of General Restorative Devices

| 510(k) Number | K973324 |
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Prescription Use X

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (per 21 CFR 801.109)