EPILASER I UPGRADE KIT

K980160 · Palomar Medical Products, Inc. · GEX · Mar 10, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980160
• Device Name: EPILASER I UPGRADE KIT
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Epilaser I is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery. The Epilaser I was limited to prescription use at the substantially equivalent decision. (March 5, 1997).

Device Story

Upgrade kit for Epilaser I ruby laser; consists of laser head with higher energy output, fiber optic beam connector (SMA 905), fiber optic cable, and modified hand pieces with quick-connect mechanism. Replaces articulated arm of original device. Used in dermatology and plastic surgery settings by physicians. Device delivers laser energy to hair follicles; melanin absorbs energy to effect hair removal. Upgrade maintains original performance characteristics and intended use.

Clinical Evidence

None required; bench testing only.

Technological Characteristics

Ruby laser surgical instrument. Upgrade components: laser head, fiber optic cable with SMA 905 connector, modified hand pieces. Replaces articulated arm delivery system. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for hair removal in patients with skin types 1-4 via selective melanin targeting in hair follicles. For use in dermatology and plastic surgery. 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

• Epilaser I (K963947)

Submission Summary (Full Text)

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# MAR 1 0 1998

: *

# K980160

## APPENDIX E

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## 510(k) SUMMARY

### Epilaser® I Normal Mode Ruby Laser

This 510(k) summary of safety and effectiveness involves a post-sale upgrade of the Epilaser I and is submitted in accordance with the requirements of SMDA 1990 following Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | Palomar Medical Technologies, Inc. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 45 Hartwell Avenue<br>Lexington, MA 02173 |
| Contact Person: | Mr. Anthony Fiorillo<br>President, Palomar Medical<br>Technologies, Inc. |
| Telephone: | 617-676-7300<br>617-676-7330 (Fax) |
| Preparation Date:<br>(of the Summary) | December 1997 |
| Device Trade Name: | Upgrade for the Epilaser® I (an accessory to the Epilaser® I). |
| Common Name: | Ruby Laser |
| Classification<br>Name | Laser surgical instrument; for use in general and plastic<br>surgery and in dermatology (see: 21 CFR 878.4810).<br>Product Code: GEX<br>Panel: 79 |
| Legally marketed<br>predicate devices | The Epilaser® I is the legally marketed device. Installation of |
| Description of<br>the Device: | The upgrade kit for the Epilaser® I consists of a laser head with<br>a slightly higher energy output, a fiber optic beam connector<br>with a standard SMA 905 connector, a fiber optic, and<br>modified hand pieces adapted with a quick connect to the fiber<br>optic. |

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| Intended Use of the Device: | The intended use Epilaser ^R I is not affected by installation of the upgrade kit. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison: | The operational specifications, performance and intended use of the Epilaser ^R I are not affected by the installation of the upgrade kit. The changes in specifications after installation of the upgrade kit, e.g., a fiber optic in place of an articulated arm, do not affect the performance characteristics of the Epilaser ^R I. |
| Performance Data: | None required. |
| SUMMARY: | Installation of the upgrade kit has no effect on the performance, instructions for use, or indications of use for the Epilaser ^R I. <p>The Epilaser^R I performance and characteristics are not affected by the installation of the upgrade kit.</p> |
| CONCLUSION: | The Epilaser ^R I laser after installation of the kit is substantially equivalent to the Epilaser ^R I prior to installation of the kit. |
| Additional Information | None requested |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three curved lines or strokes, which is the department's emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 1998

Mr. Anthony Fiorillo · President Palomar Medical Technologies, Incorporated 45 Hartwell Avenue Lexington, Massachusetts 02173

Re: K980160 Trade Name: Epilaser I Upgrade Kit Regulatory Class: II Product Code: GEX Dated: January 13, 1998 Received: January 16, 1998

Dear Mr. Fiorillo:

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. ਬੋ 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 - Mr. Fiorillo

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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980160

APPENDIX D

- NOTE: The following indications for use are quoted from the Indications for Use statement for the Epilaser as described in K963947 (the laser has been renamed the Epilasers I). The indications for use in this APPENDIX are provided for the record; the installation of : ・ the upgrade kit does not affect or alter these indications. The upgrade kit itself does not have indications for use.
510(k) Number: 长安

Epilaser I Normal Mode Ruby Laser Device Name:

Indications for Use:

The Epilaser I is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

The Epilaser I was limited to prescription use at the substantially equivalent decision. (March 5, 1997). મે જ

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--|--------------------------------------------------------|--|
|--|--------------------------------------------------------|--|

| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter-Use |
|---------------------------------------|-------------------------|
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(Division Sign-Off)
Division of General Restorative Devices

| 510(k) Number | k980160 |
|---------------|---------|
|---------------|---------|

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