SPATOUCH PHOTOEPILATION SYSTEM

K020856 · Radiancy (Israel) , Ltd. · GEX · Jun 13, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020856
• Device Name: SPATOUCH PHOTOEPILATION SYSTEM
• Applicant: Radiancy (Israel) , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SpaTouch is intended for removal of unwanted hair by using a selective photothermal treatment. The device is generally indicated for dermatological use. The SpaTouch is specifically indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional.

Device Story

SpaTouch PhotoEpilation System uses selective photothermal treatment for hair removal. Device operates via light-based energy delivery to hair follicles. Handpiece includes contact switches to ensure proper application. Intended for patient self-use under physician direction following training by healthcare professional. Output is thermal energy targeting hair; clinical benefit is removal of unwanted hair. Device is substantially equivalent to DeLight II, with addition of contact switches as primary modification.

Clinical Evidence

Clinical data demonstrated that the device can be used safely and effectively under the supervision of a health professional.

Technological Characteristics

Pulsed light hair removal system; selective photothermal treatment principle. Features handpiece with integrated contact switches. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for removal of unwanted hair via selective photothermal treatment in patients under physician direction following professional training.

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

• DeLight II Hair Removal System

Submission Summary (Full Text)

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020856 1/2

:

JUN 1 3 2002

## 510(k) SUMMARY

# Radiancy (Israel) Ltd.'s SpaTouch® PhotoEpilation System

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Radiancy (Israel) Ltd. 9 Gan Ravve Street Industrial Park Yavne Israel Telephone: [phone] Facsimile: [phone]

Jonathan S. Kahan, Esq. Contact Person: Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109 Telephone: [phone] Facsimile: [phone] Email: [e-mail]

Date Prepared: March 12, 2002

## Name of Device and Name/Address of Sponsor

| Trade/Proprietary Name: | SpaTouch® PhotoEpilation System |
|------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | Pulsed Light Hair Removal System |
| Classification Name: | Laser surgical instrument for use in<br>general and plastic surgery and in<br>dermatology (21 CFR § 878.4810) |
| Address of Manufacturing Facility: | Radiancy (Israel) Ltd.<br>9 Gan Ravve Street<br>Industrial Park<br>Yavne<br>Israel |
| Establishment Registration Number: | 9616256 |
| Owner/operator number: | 9040071 |

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2086 2/2

#### Predicate Devices

Radiancy (Israel) Ltd. DeLight II Hair Removal System

### Intended Use / Indications for Use

The SpaTouch is intended for removal of unwanted hair by using a selective photothermal treatment. The device is generally indicated for dermatological use. The SpaTouch is specifically indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional.

### Technological Characteristics and Substantial Equivalence

The SpaTouch and its predicate device are intended for removal of unwanted hair by using a selective photothermal treatment. The device is generally indicated for dermatological use. The SpaTouch is specifically indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. With the exception of contact switches added to the handpiece, the SpaTouch is the exact same device as the previously cleared DeLight II device. The only differences between the cleared DeLight II and the SpaTouch are the addition of the contact switches to the handpiece and the expanded indications for use. Neither of these differences raises new issues of safety or effectiveness. Thus, the SpaTouch can be found substantially equivalent.

#### Performance Data

Clinical data demonstrated that the device can be used safely and effectively under the supervision of a health professional.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is an emblem featuring three stylized human profiles facing to the right, stacked slightly on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2002

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

Re: K020856

Trade Name: SpaTouch® PhotoEpilation System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: May 14, 2002 Received: May 14, 2002

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Jonathan Kahan

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stupt Rlvedn

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

Enclosure

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### Page 1 of 1

### Indications for Use Form

K020856 510(k) Number (if known):___

Device Name:

SpaTouch® PhotoEpilation System

Indications for Use:

The SpaTouch PhotoEpilation System is intended for removal of unwanted hair by using a selective photothermal treatment. The device is generally indicated for dermatological use. The SpaTouch is specifically indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styt Rhode

(Division Sign-Off) Division of General, Restorative and Neurological Devices

KOZO85B 510(k) Number _

OR

Over-The-Counter

(Per 21 C.F.R. 801.109)

(Optional Format 1-2-96)

Use_

Prescription Use __ X_