RADIANCY FACIAL SKINCARE DEVICE

K052991 · Radiancy (Israel) , Ltd. · GEX · Feb 1, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052991
• Device Name: RADIANCY FACIAL SKINCARE DEVICE
• Applicant: Radiancy (Israel) , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Facial SkinCare Device is intended for use in dermatology. The Facial SkinCare Device is specifically indicated to treat benign pigmented lesions, including, but not limited to solar lentigines, ephilides (freckles), and mottled pigmentation in patients with Fitzpatrick skin types I-V.

Device Story

The Radiancy Facial SkinCare Device is a pulsed-light, manually controlled system for dermatological treatment of benign pigmented lesions. It utilizes pulsed light energy to target and treat skin conditions. The device is intended for use by healthcare professionals in a clinical setting. By delivering controlled light pulses, the device targets pigmented areas, potentially improving skin appearance. The provider operates the device manually to apply light to the affected skin areas. The device is substantially equivalent to existing pulsed light systems used for similar dermatological indications.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Pulsed-light system; manually controlled. Designed for dermatological application. Similar technological characteristics to cleared pulsed light systems for benign pigmented lesions.

Indications for Use

Indicated for treatment of benign pigmented lesions, including solar lentigines, ephilides (freckles), and mottled pigmentation in patients with Fitzpatrick skin types I-V.

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

• Radiancy, Inc. SPR System (K033181)
• Danish Dermatologic Development A/S Ellipse IPPL ™ (K043255)

Submission Summary (Full Text)

{0}------------------------------------------------

052991

#### 2006 FER I

## 510(k) SUMMARY

## Radiancy (Israel) Ltd. Radiancy Facial SkinCare Device

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

| Manufacturer: | Radiancy (Israel) Ltd.<br>9 Gan Rave Street<br>Industrial Park<br>Yavne<br>Israel |
|---------------|-----------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Facsimile: | [phone] |

| Contact Person: | Margaret Fourte<br>Director, Clinical and Regulatory Affairs<br>Radiancy, Inc.<br>40 Ramland Road<br>Orangeburg, NY 10972<br>Telephone: [phone]<br>Facsimile: [phone]<br>Email: [e-mail] |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | January 20, 2006 |

### Name of Device and Name/Address of Sponsor

| Trade/Proprietary Name: | Radiancy Facial SkinCare Device |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | Pulsed Light System and Light Unit Assembly |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology (21 C.F.R. § 878.4810) |

| Manufacturing Facility: | Radiancy (Israel) Ltd. |
|-------------------------|------------------------|
| | 9 Gan Rave Street |
| | Industrial Park |
| | Yavne, Israel |

| Establishment | |
|------------------------|---------|
| Registration Number: | 9616256 |
| Owner/operator number: | 9040071 |

{1}------------------------------------------------

K0.52991

### Predicate Devices

Radiancy, Inc. SPR System (K033181)

Danish Dermatologic Development A/S Ellipse IPPL ™ (K043255)

#### Device Description

The Radiancy Facial SkinCare Device is a pulsed-light, manually controlled system designed to treat benign pigmented lesions.

#### Intended Use / Indications for Use

The Facial SkinCare Device is intended for use in dermatology. The Facial SkinCare Device is specifically indicated to treat benign pigmented lesions, including, but not limited to solar lentigines, ephilides (freckles), and mottled pigmentation in patients with Fitzpatrick skin types I-V.

#### Technological Characteristics

The Facial SkinCare Device that is the subject of this 510(k) notice is similar to devices already cleared to treat benign pigmented lesions.

### Substantial Equivalence

The Radiancy Facial SkinCare Device has the same intended use and one of the same indications for use, same principles of operation and same technological characteristics as the Radiancy SPR System and the Ellipse I PL™, which have already been cleared to treat benign pigmented lesions. The minor differences between the Radiancy Facial SkinCare Device and the predicates do not raise new issues of safety and effectiveness. Thus, the Radiancy Facial SkinCare Device is substantially equivalent.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services in the USA. The seal is circular and features an abstract eagle design in the center. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Radiancy (Israel) Ltd. c/o Ms. Margaret Fourte Director, Clinical and Regulatory Affairs Radiancy, Inc. 40 Ramland Road South, Suite 10

Re: K052991

Orangeburg, New York 10962

Trade/Device Name: Radiancy Facial SkinCare Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 22, 2005 Received: December 23, 2005

FER I

2006

, 1

ત્

Dear Ms. Fourte:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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.

{3}------------------------------------------------

#### Page 2 - Ms. Fourte

This letter will allow you to begin marketing your device as described in your Section 510(k) r market 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Barbara Buckner

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Page 1 of 1 Indication for Use Form

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K052991 --

#### Radiancy Facial SkinCare Device Device Name:

Indications for Use:

The Radiancy Facial SkinCare Device is intended for dermatological use. The Facial SkinCare Device is specifically intended to treat benign pigmented lesions, i ablar onlinears botted to solar lentigines, ephilides (freckles), and mottled pigmentation in patients with Fitzpatrick skin types I-V.

, i

く

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use__ (Per 21 C.F.R. 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | for MXM |
|--|---------|
|--|---------|

(Division Sign-Off)
Division of General Restorative,
and Neurological Devices510(k) N