DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)

K992482 · Radiancy, Ltd. · GEX · Dec 27, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992482
• Device Name: DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)
• Applicant: Radiancy, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DeLight™ II HR System is a light-based medical device intended for removal of unwanted hair by using a selective photothermal treatment. The device is speciffically indicated for dermatological use.

Device Story

Light-based medical device for selective photothermal hair removal; operates via manual user control. Emits light pulses to target hair follicles; intended for dermatological use by physicians and healthcare professionals. Clinical benefit includes removal of unwanted body and facial hair. Device operates at lower fluence levels than predicate; utilizes single pulse light delivery. Clinical decision-making supported by physician assessment of skin type and hair color.

Clinical Evidence

IRB-approved human clinical trial evaluated clearance rates and side effects across various skin types and hair colors. Results compared to published data for the predicate device. Study concluded the system is safe and effective.

Technological Characteristics

Light-based hair removal system; selective photothermal treatment. Operates at lower fluence levels than predicate; single pulse light delivery. Manually controlled by user. Class II device.

Indications for Use

Indicated for removal of unwanted body and/or facial hair in adults. For dermatological use by physicians and healthcare professionals.

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)

Submission Summary (Full Text)

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# K992482

## 510(k) Summary

## Radiancy (Israel) Ltd.'s DeLight™ II HR System

| Submitter's name: | Radiancy (Israel) Ltd. |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Submitter's address: | Lev Hatamar Building<br>4 Pekeris St.,<br>Rabin Science Based Industrial Park<br>Rehovot 76702<br>ISRAEL |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Simona Konkol, Director of Regulatory Affairs. |
| Preparation Date: | July 22, 1999 |
| Device Trade Name: | DeLight™ II HR System |
| Common Name: | Light Based Hair Removal System |
| Classification Name: | Laser Surgical Instrument pursuant to 21 CFR 878.4810 |

Predicate Device:

EpiLight® Hair Removal System, manufactured by ESC Medical Systems Ltd. of Yokneam, Israel, 510(k) #K963249.

#### Description of the Device:

The DeLight™ II HR System is a light-based medical device intended for removal of unwanted hair by using a selective photothermal treatment.

### Intended Use:

The DeLight™ II HR System is a light-based medical device intended for removal of unwanted hair by using a selective photothermal treatment. The device is speciffically indicated for dermatological use.

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#### Comparison of Technological Characteristic:

Radiancy has performed a detailed side-by-side comparison of the technical specification of the predicate device and the DeLight™ II HR System. The results have shown that the system specifications of the DeLight™ II HR System are substantially equivalent to the technical specifications of the cleared EpiLight® System. The DeLight™ II HR System has few differences from the predicate device, for example, the DeLight™ II HR operates at lower fluence levels than the predicate device and uses one pulse light while the predicate device uses multiple pulses with variable pulse width. The predicate device is computer controlled while the DeLight™ II HR System is controlled manually by the user. However, these minor differences do not raise new questions of safety or efficacy, thus the DeLight™ II HR System is substantially equivalent to its predicate device.

#### Clinical Performance Data:

The DeLight™ II HR System has been studied in an IRB approved human clinical trial, in which various skin types and various hair colors were treated by the DeLight™ II HR System. Clearance rates and occurrence of side effects were examined. The data was compared to published data on the clearance and side effects of the predicate device. The clinical results and the comparison to the predicate device demonstrate that the DeLight™ II HR System is safe and effective. Thus, the DeLight™ II HR System is substantially equivalent to the predicate device.

Non-Clinical Performance Data: None required.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with three lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 27 1999

Radiancy Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109

Re: K992482 Trade Name: DeLight II HR System Regulatory Class: II Product Code: GEX Dated: December 1, 1999 Received: December 1, 1999

Dear Mr. Kahan:

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 - Mr. Jonathan S. Kahan

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,

Nessel/Sager

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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#### INDICATION FOR USE STATEMENT

15992482 510 (k) Number:_____ New Submission

Device Name: ______ DeLight™ II HR System_____________________________________________________________________________________________________________________________________

Indications for use:

The DeLight™ II HR System is intended for removal of unwanted body and/or facial hair in adults.

The System is specifically indicated for dermatological use by physicians and healthcare professionals.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Russell Sage for Trp

(Division Sign-Off) Division of General Restora 51U(k) Number _

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use -------