PALOMAR SLP 2000

K994225 · Palomar Medical Technologies, Inc. · GEX · May 18, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K994225
• Device Name: PALOMAR SLP 2000
• Applicant: Palomar Medical Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SLP™ 2000 Diode Laser System is indicated to remove hair in Dermatology and Plastic Surgery procedures. It is also intended for Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions.

Device Story

Infrared diode laser (810 nm) system; delivers selectable pulse durations (50-1000 ms) and energy (0.5-100 J). System includes laser unit, chiller, footswitch, and water-cooled handpiece. Operated by clinicians in dermatology/plastic surgery settings. Handpiece pressed against patient skin; footswitch triggers light pulse. Active skin cooling provided via water-cooled tip. Laser parameters controlled via user interface panel. Device facilitates hair removal and vascular lesion treatment through photothermolysis; benefits include non-invasive tissue treatment.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance specifications compared to the predicate device.

Technological Characteristics

810 nm infrared diode laser; 50-1000 ms pulse duration; 0.5-100 J pulse energy; 5 Hz max repetition frequency. Features water-cooled handpiece for active skin cooling. System includes laser unit, chiller, and footswitch. Controlled via computer-based user interface.

Indications for Use

Indicated for hair removal (skin types I-VI), photocoagulation of dermatological vascular lesions (port wine stains, telangiectasia, angioma, spider nevi, benign vascular lesions), photothermolysis of blood vessels (facial/leg veins), and removal of pigmented lesions in dermatology and plastic surgery patients.

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 Diode Array Laser (K973324)

Submission Summary (Full Text)

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## Attachment V

K994225

## 510(K) Summary of Safety and Effectiveness

This 510(K) Summary of Safety and Effectiveness for the SLP™ 2000 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: | Palomar Medical Technologies, Inc. |
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| Address: | 82 Cambridge St.<br>Burlington, MA 01803 |
| Contact Person: | Marcy Moore |
| Telephone: | 919-363-2432 |
| Preparation Date: | November 15, 1999 |
| Device Trade Name: | Palomar SLP™ 2000 |
| Common Name: | Super Long Pulse Diode 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: | LightSheer Diode Array Laser<br>Star Medical Technologies, Inc.<br>K973324 |
| System Description: | The SLP™ 2000 delivers infrared laser light<br>with a wavelength of 810 nm, a selectable pulse<br>duration of 50 - 1000 ms, and a selectable pulse<br>energy of .5-100 J. The corresponding fluence<br>delivered through a 10 mm handpiece tip. The laser<br>pulses are generated at a maximum pulse repetition<br>frequency of 5 Hz by diodes located in the laser<br>unit |

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| | The complete system consists of a laser unit, chiller, a footswitch, and a handpiece connected to the laser unit with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch is depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the user interface panel on top of the laser unit, which provides an interface to the system computer. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Intended Use of the Device:</b> | The SLP™ 2000 Diode Laser System is indicated to remove hair in Dermatology and Plastic Surgery procedures. It is also intended for Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. |
| <b>Performance Data:</b> | The differences in the specifications of the SLP™ 2000 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy. |
| <b>Conclusion:</b> | Based on the foregoing, the SLP™ 2000 Diode Array Laser System is substantially equivalent to the legally-marketed claimed predicate device, i.e., the LightSheer™ for hair removal. |

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# MAY 1 8 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Palomar Medical Technologies, Inc. c/o Ms. Marcy Moore Manager of Clinical Studies 131 Kelekent Lane Gary, North Carolina 27511

Re: K994225

Trade Name: Palomar SLP™ 1000 Regulatory Class: II Product Code: GEX Dated: March 27, 2000 Received: March 29, 2000

#### 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 (QS) 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 vour 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 vours.

Purnell Page

& & Celia M. Witten, Ph.D., M.D. 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 STATEMENT

510(K) Number: K994225________________________________________________________________________________________________________________________________________________________

Palomar SLP™ 1000 Device Name:

Indications for Use:

The Palomar Super Long Pulse, SLP™ 1000, diode laser system is indicated for I no rulomar buper and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin. subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph suboutined about and glands, and glands, and specifically for the following indications.

Dermatology and Plastic Surgery for: Hair Removal in Skin Types I-VI Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions Photothermolysis

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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I limal (Division Sign-Off) Division of General Restorative Devices K994228 510(k) Number .

Prescription Use (per 21 CFR 801.109)

OR

Over-the-Counter Use