ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT

K994014 · Esc Medical Systems , Ltd. · GEX · Feb 24, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K994014
• Device Name: ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT
• Applicant: Esc Medical Systems , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™, are used for the removal of unwanted hair from all skin types.

Device Story

IPL device uses intense pulsed light to target and remove unwanted hair. Operated by clinicians in a professional setting. Device delivers light pulses to skin; energy absorption by hair follicles leads to hair removal. Clinical effectiveness and safety for skin type VI patients established via multi-center study documenting clearance rates and adverse effects. Output used by clinicians to guide treatment parameters and assess hair removal progress. Benefits include effective hair removal across diverse skin tones.

Clinical Evidence

Multi-center study conducted to evaluate clinical effectiveness of IPL devices for hair removal in skin type VI patients. Study documented hair clearance rates and adverse effects. Results support substantial equivalence to performance in skin types I-V.

Technological Characteristics

Intense Pulsed Light (IPL) system; powered surgical laser instrument (Product Code GEX). Class II medical device. Operates via light-based energy delivery for hair removal.

Indications for Use

Indicated for the removal of unwanted hair in patients of all skin types, including skin type VI.

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

• ESC EpiLight® Hair Removal System
• ESC PhotoDerm® HR

Submission Summary (Full Text)

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994014

FEB 2 4 2000

## 510(K) PREMARKET NOTIFICATION

Hair removal for skin type VI patients
ESC Medical Systems Ltd.

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## 510(K) Summary

| Submitter: | ESC Medical Systems Ltd.<br>Yokneam Industrial Park<br>Yokneam,20692, Israel<br>Phone: [phone] Fax: [phone] |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Zvi Ladin, VP, Clinical Applications and Regulatory Affairs<br>ESC Inc.<br>250 First Avenue<br>Needham, MA 02495<br>Phone: [phone] Fax: [phone] |
| Date summary prepared: | November 23, 1999 |
| Device Trade Name: | IPLTM Device for hair removal |
| Common name: | EpiLight®; MultiLightTM |
| Classification name: | Laser instrument, powered, surgical (class II medical device) |
| Equivalent Devices: | ESC EpiLight® Hair Removal System<br>ESC PhotoDerm® HR |
| Clinical Information: | A multi-center study was conducted to examine the clinical effectiveness of<br>IPLTM devices in the removal of unwanted her. The study documented the<br>clearance rate and the adverse effects obtained when treating skin type VI patients<br>using an IPLTM device. |
| Intended Use: | Removal of unwanted hair in patients with skin type VI |
| Conclusion: | IPLTM devices used to treat skin type VI patients are substantially equivalent in<br>their level of safety and effectiveness to that obtained when using the same<br>devices to treat patients with skin types I - V |
| Additional Information: | None requested at this time |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 4 2000

Dr. Zvi Ladin Corporate Vice President Clinical and Regulatory Affairs ESC Medical Systems Ltd. 250 First Avenue, Suite 300 Needham. Massachusetts 02494

Re: K994014 Trade Name: EpiLight and MultiLight™ Regulatory Class: II Product Code: GEX Dated: November 24, 1999 Received: November 26, 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 (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 - 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,

Numill Vayen

& 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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510(k) Number (if known):

Device Name:

ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™

Indications For Use:

ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™, are used for the removal of unwanted hair from all skin types.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|----------------------------------------------------------------|----------------------|
| | | |
| | (Division Sign-Off)<br>Division of General Restorative Devices | |
| 510(k) Number | K994014 | |
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109 | | |

(Optional Format 1-2-96)