EPILASER NORMAL MODE RUBY LASER

K980517 · Palomar Medical Products, Inc. · GEX · Jul 21, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980517
• Device Name: EPILASER NORMAL MODE RUBY LASER
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EpiLaser™ Normal Mode Ruby Laser is intended to effect a permanent reduction of hair in patients with skin types I-IV through selective targeting of melanin in hair follicles.

Device Story

EpiLaser™ Normal Mode Ruby Laser operates at 694.3 nm wavelength; delivers laser energy via articulated arm to treatment sites. Features water-cooled handpiece with 7 or 10 mm spot sizes; pulse duration 0.2 to 3.0 msec; energy fluences 10-60 J/cm2. Used by clinicians in dermatology/surgery settings to target melanin in hair follicles. Output is laser energy; clinical effect is permanent hair reduction. Benefits include long-term stable reduction in hair regrowth without scarring or depigmentation.

Clinical Evidence

Clinical study evaluated hair and skin responses at 1, 3, 6, 9, 12, and 24 months post-treatment. Results indicated permanent hair reduction with no observed scarring or depigmentation.

Technological Characteristics

Ruby laser; 694.3 nm wavelength; 0.2-3.0 msec pulse duration; 10-60 J/cm2 fluence. Water-cooled handpiece; 7 or 10 mm spot sizes. Articulated arm delivery system. Class II device.

Indications for Use

Indicated for 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

• EpiLaser™ Normal Mode Ruby Laser (K963947)

Submission Summary (Full Text)

{0}------------------------------------------------

Jul 21 1998

K980517

## Attachment 6

510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EpiLaser™ Normal Mode Ruby I has sions builted 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 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 45 Hartwell Avenue<br>Lexington, MA 02 |
| Contact Person: | Tony Fiorillo |
| Telephone: | 781-676-7300 |
| Preparation Date: | February 3, 1998 |
| Device Trade Name: | EpiLaser™ Normal Mode Ruby Laser |
| Common Name: | Ruby 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>Palomar Medical Products<br>k963947 |
| System Description: | The EpiLaser™ operates at a wavelength of 694.3<br>nanometers and the beam has a pulse duration of 0.2<br>to 3.0 milliseconds (msec). The laser energy is<br>delivered to the treatment sites by an articulated<br>arm. Energy fluences of 10-60 J/cm2 are achieved<br>under conditions of intended use. A water-cooled<br>handpiece (spot sizes of 7 or 10 mm) is held firmly<br>against the treatment site. |

{1}------------------------------------------------

Intended Use of the Device:

The EpiLaser™ Normal Mode Ruby Laser is intended to effect a permanent reduction of hair in patients with skin types I-IV through selective targeting of melanin in hair follicles.

There are no technological differences.

Performance Data:

Results of Clinical Study:

ﻪ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

Observations of hair and skin responses were recorded prior to treatment and at 1, 3, 6, 9, 12 and 24 months after treatment. There was no scarring or depigmentation of the skin in any subject. The study demonstrated that EpiLaser™ is a safe and effective tool for hair removal, resulting in a permanent reduction of hair.

Conclusion:

Based on the foregoing, the EpiLaser™ is effective for producing a permanent reduction of hair.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which consists of a stylized human figure with three heads, representing the department's focus on health, well-being, and human services. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is simple and recognizable, conveying the department's mission and purpose.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 21 1998

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

Re : K980517 Trade Name: EpiLaser™ Normal Mode Ruby Laser Regulatory Class: II Product Code: GEX Dated: June 12, 1998 Received: June 15, 1998

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 legally marketed predicate 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). Permanent hair reduction, in the context of this indication for use, shall mean a long term, stable reduction in the number of hairs regrowing after a treatment regime. It shall not permit a claim using the terms permanent elimination or permanent removal of all hair in the treated area after a You may, therefore, market the device, subject to treatment. 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 Requlations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice reguirements, 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

{3}------------------------------------------------

## Page 2 - Ms. Marcy Moore

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 requlations.

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

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

Enclosure

{4}------------------------------------------------

K980517

## INDICATIONS FOR USE

The LipiLaser® is intended to effect temporary hair reduction in skin types I-IV . The LipiLaser® 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.

**Prescription Use**
(Per 21 CFR 801.109)

pcseel

oral Restore