EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM

K991935 · Esc Medical Systems , Ltd. · GEX · Jan 27, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K991935
• Device Name: EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM
• Applicant: Esc Medical Systems , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EpiLight® and PhotoDerm® HR are used for the removal of unwanted hair. EpiLight® and PhotoDerm® HR are also intended to effect stable long-term, or permanent hair reduction in skin types I-V 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

EpiLight® and PhotoDerm® HR are electro-optical medical devices for photothermal hair removal. Devices utilize intense pulsed light to target melanin in hair follicles; process results in stable long-term or permanent hair reduction. Systems are operated by healthcare professionals in clinical settings. Output consists of controlled light pulses; provider uses output to perform hair removal procedures. Clinical benefit is reduction of unwanted hair.

Clinical Evidence

Clinical trials were performed to establish substantial equivalence. No specific performance metrics (e.g., p-values, CIs) are provided in the summary document.

Technological Characteristics

Electro-optical medical device; intense pulsed light source; designed for photothermal treatment; targets melanin in hair follicles; intended for skin types I-V.

Indications for Use

Indicated for removal of unwanted hair and stable long-term or permanent hair reduction in skin types I-V. Targets 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

• EpiLight® Hair Removal System (K963249)
• PhotoDerm® HR (K974536)
• EpiLaser™ Normal Mode Ruby Laser (K980517)
• LightSheer™ Long Pulse Ruby Laser (K982980)
• LightSheer™ Pulsed Diode Array Laser System (K982940)

Submission Summary (Full Text)

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# JAN 2 7 2000

#### I. 510(K) SUMMARY OF SAFETY AI FFECTIVENESS

ESC Medical Systems, Ltd Submitter's name:

Submitter's address: Yokneam Industrial Park PO Box 240 Yokneam 20692 ISRAEL

011-972-4-959-9000 Telephone:

001-972-4-959-9050 Fax:

EpiLight®, PhotoDerm® HR Names of devices:

Predicate devices:

- 1) EpiLight® Hair Removal System, made by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K963249
- 2) PhotoDerm® HR , Made by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K974536
- 3) EpiLaser™ Normal Mode Ruby Laser made by Palomar Medical Products of N. Carolina USA. 510(k) #980517.
- 4) LightSheer™ Long Pulse Ruby Laser made by Palomar Medical Products of N. Carolina USA. 510(k) #982980.
- 5) LightSheer™ Pulsed Diode Array Laser System made by Star Medical Technologies of Pleasanton CA, USA 510(k) #K982940.

Description of device:

EpiLight® and PhotoDerm® HR are electro-optical medical devices designed for effective photothermal treatment of unwanted hair and its removal.

Summary:

Pursuant to section 513(I) of the Safe Medical Devices Act of 1990, ESC Medical Systems has elected to include in this premarket notification a Summary of Safety and Effectiveness upon which we believe a substantial equivalence determination for the EpiLight® Hair Removal System and the PhotoDerm® HR can be based.

Intended use:

EpiLight® and PhotoDerm® HR are used for the removal of unwanted hair.

EpiLight® and PhotoDerm® HR are also intended to effect stable long-term, or permanent hair reduction in skin types I-V 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.

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### Comparing technical characteristics:

Both a technical comparison and clinical trials were performed by ESC Medical Systems to establish the substantial equivalence to the predicate devices.

No performance standards applicable to the PhotoDerm® HR have been adopted under Section 514 of the Act.

In summary we believe that the analysis and clinical data establish that the PhotoDerm® HR is substantially equivalent to the predicate devices.

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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 in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2000

Dr. Zvi Ladin Corporate Vice President, Clinical and Regulatory Affairs ESC Medical Systems LTD U.S. Operations 250 First Avenue Needham, Massachusetts 02494

Re: K991935

> Trade Name: Epiderm Hair Removal System and PhotoDerm Hair Removal System Regulatory Class: II Product Code: GEX Dated: October 26, 1999 Received: October 27, 1999

Dear Dr. Ladin:

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 (OS) 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 - Dr. Zvi Ladin

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,

James E. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K991935 510(k) Number (if known):

ESC Family of Intense Pulsed Light Hair Removal Device Name: Systems: EpiLight® and PhotoDerm® HR

Indications For Use:

# EpiLight®

EpiLight® is used for the removal of unwanted hair.

EpiLight® is also intended to effect stable long-term, or permanent hair reduction in skin types I-V 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.

# PhotoDerm® HR

PhotoDerm HR is used for the removal of unwanted hair.

PhotoDerm® HR is also intended to effect stable long-term, or permanent hair reduction in skin types I-V 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.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
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| Division of General Restorative Devices | |
| 510(k) Number | K991935 |

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)