STARLIGHT PULSED DIODE ARRAY LASER SYSTEM

K974346 · Star Medical Technologies, Inc. · GEX · Jan 16, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974346
• Device Name: STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
• Applicant: Star Medical Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 16, 1998
• 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 for the treatment of leg veins in Dermatology and Plastic Surgery procedures.

Device Story

StarLight Pulsed Diode Array Laser System delivers 800 nm infrared laser light for leg vein treatment. System comprises console, footswitch, and water-cooled handpiece. Physician operates device by pressing handpiece against patient skin and triggering pulse via footswitch/handpiece button. Console touch-screen interface controls laser parameters (5–30 ms pulse duration; 10–40 J/cm² fluence). Laser energy induces vessel coagulation, diameter reduction, and disappearance. Active cooling protects skin during procedure. Intended for clinical use in Dermatology and Plastic Surgery.

Clinical Evidence

Clinical study conducted to evaluate vessel clearing and skin response. Observed outcomes included vessel diameter reduction, coagulation, and disappearance. No instances of scarring or permanent depigmentation reported. Study concluded the device is safe and effective for leg vein treatment.

Technological Characteristics

Pulsed diode array laser; 800 nm wavelength; 5–30 ms pulse duration; 10–40 J/cm² fluence; 9 x 9 mm handpiece tip; water-cooled handpiece for active skin cooling; console-based touch-screen control interface; 1 Hz maximum pulse repetition frequency.

Indications for Use

Indicated for the treatment of leg veins in patients undergoing Dermatology or Plastic Surgery procedures. Prescription use only.

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

• PhotoGenica LPIR™

Submission Summary (Full Text)

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k974346

JAN 16 1998

# Attachment 9

## 510(K) Summary of Safety and Effectiveness

This 510(K) Summary of Safety and Effectiveness for the StarLight™ Pulsed Diode Array Laser System 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.

Address: 1249 Quarry Lane, Suite 100
Pleasanton, CA 94566

Contact Person: Robert E. Grove, Ph.D.

Telephone: [phone]

Preparation Date: November 14, 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 Plastic Surgery and in Dermatology (see: 21 CFR 878-4810).
Product Code: GEX
Panel: 79

Legally-Marketed Predicate Device: PhotoGenica LPIR™
Cynosure, Inc.

System Description: The StarLight system delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 – 30 ms, and a selectable fluence of 10 – 40 J/cm². The corresponding pulse energy delivered through the 9 x 9 mm handpiece tip is 8 – 32 J. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode lasers located in the handpiece.

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The complete system consists of a console, a footswitch, and a handpiece connected to the console with an umbilical. In standard use, the handpiece is pressed against the patient’s skin and a light pulse is delivered when the footswitch and handpiece trigger are depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the touch-screen on top of the console, which provides an interface to the system computer.

**Intended Use of the Device:**

The StarLight Pulsed Diode Array Laser System is intended for the treatment of leg veins in Dermatology and Plastic Surgery procedures.

**Performance Data:**

Clinical studies were conducted to provide assurance that differences in the specifications of the StarLight system and the predicate device do not result in different performance or raise new questions of safety or efficacy.

**Results of Clinical Study:**

Observations of vessel clearing and skin responses were recorded as a function of vessel and treatment parameters. Vessel effects included reduction in vessel diameter, vessel coagulation, and vessel disappearance. There was no scarring or permanent depigmentation of the skin in any subject. The study demonstrated that the StarLight Pulsed Diode Array Laser System is a safe and effective tool for the treatment of leg veins.

**Conclusion:**

Based on the foregoing, the StarLight Pulsed Diode Array Laser System is substantially equivalent to the legally-marketed claimed predicate device for the purposes of this 510(K) submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
JAN 16 1998

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

Re: K974346
Trade Name: StarLight™ Pulsed Diode Array Laser System
Regulatory Class: II
Product Code: GEX
Dated: November 14, 1997
Received: November 19, 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 (QS) 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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K974346

# INDICATION FOR USE STATEMENT

510(K) Number: Pending

Device Name: StarLight™ Pulsed Diode Array Laser System

Indications for Use:

The StarLight™ Pulsed Diode Array Laser System is intended for the treatment of leg veins in Dermatology and Plastic Surgery procedures.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑

OR Over-the-Counter Use ☐

(per 21 CFR 801.109)