LIGHTSHEER LONG PULSE RUBY LASER

K982980 · Palomar Medical Products, Inc. · GEX · Mar 4, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K982980
• Device Name: LIGHTSHEER LONG PULSE RUBY LASER
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 4, 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 in skin types I-IV. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction in skin types I-IV 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™ Long Pulse Ruby Laser; operates at 694.3 nm wavelength; delivers energy fluences of 10-60 J/cm² with pulse durations of 3 and 20 ms. Device utilizes a thermoelectrically cooled handpiece held against treatment site. Targeted at melanin in hair follicles to achieve hair reduction. Used in clinical settings by trained professionals. Output is laser energy; clinical benefit is stable long-term or permanent hair reduction.

Clinical Evidence

No clinical data required; substantial equivalence established via technological comparison.

Technological Characteristics

Ruby laser system; 694.3 nm wavelength; 3 and 20 ms pulse durations; 10-60 J/cm² energy fluence; thermoelectrically cooled handpiece.

Indications for Use

Indicated for temporary or stable long-term/permanent hair reduction in patients with skin types I-IV 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™ Long Pulse Ruby Laser (K980420)
• EpiLaser® Normal Mode Ruby Laser (K980517)

Submission Summary (Full Text)

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8/4/99

Kg82980

## Attachment 2

510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness for the LightSheer™ Long Pulse Ruby 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: | Palomar Medical Products<br>Anthony Fiorillo, President | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Address: | 45 Hartwell Avenue<br>Lexington, MA 02<br>781-676-7300 | |
| Contact Person: | Marcy Moore<br>Manager of Clinical Studies | |
| Telephone: | 919-676-7166 | |
| Fax: | 919-676-3683 | |
| Preparation Date: | August 24, 1998 | |
| Device Trade Name: | LightSheer™ Long Pulse Ruby Laser | |
| Common Name: | Ruby Laser, long pulse | |
| 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™ Long Pulse Ruby Laser<br>Palomar Medical Products<br>k980420<br>EpiLaser® Normal Mode Ruby Laser<br>Palomar Medical Products<br>k980517 | |
| System Description: | The LightSheer™ operates at a wavelength of 694.3<br>nanometers and the beam has a pulse duration of 3<br>and 20 milliseconds. Energy fluences of 10-60 J/cm² | |

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are achieved under conditions of intended use. A
thermoelectrically cooled handpiece is held firmly
against the treatment site.

| Intended Use of the Device: | The LightSheer™ is intended to effect temporary<br>hair reduction in skin types I-IV. The LightSheer™<br>is also intended to effect stable long-term, or<br>permanent, hair reduction in skin types I-IV through<br>selective targeting of melanin in hair follicles.<br>Permanent hair reduction is defined as a long-term<br>stable reduction in the number of hairs regrowing<br>after a treatment regime. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | There are no technological differences. |
| Clinical Data: | None required. |
| Conclusion: | Based on the foregoing, the LightSheer™ is effective<br>for producing a stable long-term, 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three wing-like extensions.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 1999

Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Products, Inc. 9516 Candor Oaks Drive Raleigh, North Carolina 27615

> K982980 Trade Name: LightSheer™ Long Pulse Ruby Laser Regulatory Class: II Product Code: GEX Dated: January 11, 1999 Received: January 12, 1999

Dear Ms. Moore:

Re:

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 (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 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,

Stipt Rivelo

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: _______________________________________________________________________________________________________________________________________________________________

Device Name: LightSheer ™ Long Pulse Ruby Laser

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">X</span> |
|------------------|---------------------------------------------------|
|------------------|---------------------------------------------------|

OR Over-the-Counter Use

(per 21 CFR,801,109)

Stpt. K982980

(Division-Off)

Division of General Restorative Devices

513(k) Number