ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002

K030338 · Curelight, Ltd. · GEX · Feb 12, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030338
• Device Name: ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002
• Applicant: Curelight, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 12, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iClear Phototherapy System is intended to provide phototherapeutic light to the body. The iClear is generally indicated to treat dermatological conditions. The iClear is specifically indicated to treat moderate inflammatory acne vulgaris.

Device Story

iClear Phototherapy System is a high-intensity lamp device for dermatological treatment. It emits visible light in the violet-blue spectral range (50-200 mW/cm²). The system consists of a spectral band light source, an optical system for beam control, a mechanical fixture for positioning the light relative to the skin, and a timer unit for treatment duration. It is used to treat moderate inflammatory acne vulgaris. The device is operated by healthcare providers to deliver phototherapy to the skin treatment area.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

High-intensity lamp emitting violet-blue visible light (50-200 mW/cm²). Includes spectral band light source, optical system for beam/spectra control, mechanical fixture for adjustable positioning, and a timer unit. Standalone device.

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris and other dermatological conditions.

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

• CureLight Ltd.'s ClearLight

Submission Summary (Full Text)

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030338

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# 510(k) SUMMARY

# CureLight's iClear

FEB 1 2 2003

CureLight Ltd. 2 Ha'ilan Street Northern Industrial Zone, POB 247 Or Akiva 30600, Israel.

| Phone: | [phone] |
|------------|----------------|
| Facsimile: | [phone] |

Contact Person: Dr. Yoram Harth

January 31, 2003 Date Prepared:

# Name of Device and Name/Address of Sponsor

iClear Phototherapy Device, Model FGCM0002

CureLight Ltd. 2 Ha'ilan Street Northern Industrial Zone, POB 247 Or Akiva 30600, Israel

#### Common or Usual Name

Light Therapy Device

#### Classification Name

Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology

#### Predicate Devices

CureLight Ltd.'s ClearLight

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030338 2/2

#### Intended Use

The iClear Phototherapy System is intended to provide phototherapeutic light to the body. The iClear is generally indicated to treat dermatological conditions. The iClear is specifically indicated to treat moderate inflammatory acne vulgaris.

#### Technological Characteristics

The iClear Therapy System is a high intensity lamp intended for the therapy of dermatological disorders such as moderate inflammatory acne vulgaris by emitting visible light in the violet-blue range with fluency of light ranging between 50-200 mW/cm². The system includes a spectral band light source with spectral emittance concentrated in the violet/blue spectral band and an optical system for controlling spectra and beam parameters of the light source. It also includes a mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area, and an timer unit to indicate the duration of light treatment.

# Substantial Equivalence

The iClear has the same intended use indications for use and similar principles of operation, and technological characteristics as the CureLight ClearLight. Thus, iClear is substantially equivalent to its predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other. The faces are rendered in a flowing, abstract style.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 2 2003

Curelight, LTD c/o Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004

Re: K030338 Trade/Device Name: iClear Phototherapy System, Model FGCM0002 Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: January 31, 2003 Received: January 31, 2003

Dear Mr. Kahan:

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. Iisting 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

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Page 2 - Mr. Jonathan S. Kahan

(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. 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), 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

uriam C. Provost

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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Indications for Use Form

510(k) Number (if known): KO 30 30 33 P

Device Name: iClear

Indications for Use:

The iClear Phototherapy System is intended to provide phototherapeutic light to the body. The iClear is generally indicated to treat dermatological conditions. The iClear is specifically indicated to treat moderate inflammatory acne vulgaris.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use (Per 21 C.F.R. 801.109) (Optional Format 1-2-96)

Miriam C. Provost

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

510(k) Number_KC30338