CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420

K013623 · Curelight, Ltd. · GEX · Aug 16, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013623
• Device Name: CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420
• Applicant: Curelight, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

ClearLight Phototherapy System (Model CL 420) is a high-intensity lamp device for dermatological treatment. It emits visible light in the violet-blue spectral band (50-200 mW/cm² fluency) to eradicate P. acnes bacteria via endogenic porphyrins. The system features an optical assembly for beam control, a mechanical fixture for positioning, and an electronic control console with a touch screen. A camera captures digital images of the treatment area. The device is operated by healthcare professionals in a clinical setting. The control console manages radiation duration and power while storing patient data. Output allows clinicians to monitor treatment progress and adjust parameters, facilitating targeted phototherapy for acne management.

Clinical Evidence

Clinical trial data supports safety and effectiveness for treating acne vulgaris. In vitro testing confirmed that high-intensity narrow-band light eradicates P. acnes via endogenic porphyrins. Bench testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2, EN 55011), and photobiological safety (ANSI/ESNA RP-27.1-96, RP-27.3-96).

Technological Characteristics

High-intensity lamp system; spectral band light source (violet-blue); optical system for beam/spectra control; mechanical fixture for adjustable positioning; electronic control unit with touch screen; digital camera. Complies with IEC 60601-1, IEC 60601-1-2, and ANSI/ESNA RP-27 standards.

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris.

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

• Avex Industries, Inc.'s Phototherapeutix
• National Biological Corporation's Derma-Wand
• PhotoMedex, Inc.'s XTrac Excimer Laser System, Model AL 7000
• Respironics, Inc.'s Wallaby 3 Phototherapy System

Submission Summary (Full Text)

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8/16/02

#### 510(k) SUMMARY

# CureLight's ClearLight Phototherapy Device (K013623)

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

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

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

Dr. Yoram Harth Contact Person:

August 7, 2002 Date Prepared:

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

ClearLight Phototherapy Device, Model CL 420

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

# Common or Usual Name

Light Therapy Device

#### Classification Name

Ultraviolet Dermatological Light

#### Predicate Devices

Avex Industries, Inc.'s Phototherapeutix National Biological Corporation's Derma-Wand PhotoMedex, Inc.'s XTrac Excimer Laser System, Model AL 7000 Respironics, Inc.'s Wallaby 3 Phototherapy System

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## Intended Use / Indications for Use

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

# Technological Characteristics

The ClearLight Therapy System is a high intensity lamp intended for the therapy of dermatological disorders such as 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, an electronic unit to control the duration, and power of the emitted radiation and to capture and store patient data via a touch screen (i.e., control console), and a camera for capturing digital images.

## Performance Data

The preclinical testing includes Electrical Safety and EMC testing, including the requirements of IEC 60601-1 "Medical Electrical Equipment Part 1 - General Requirements for Safety" and was tested in accordance to Medical Directive 93/42/EEC - EN 55011: 1998 + A1(99). Class A and IEC 60601-1-2 "Collateral Standard: Medical El'ectrical Equipment Electromagnetic Compatibility - Requirements and Tests." ANSI/ESNA RP-27 1-96 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements ANSI/ESNA RP-27.3-96 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification Labeling.

In vitro testing demonstrated that exposure to high intensity narrow band light induced eradication of p. acnes by endogenic porphyrins.

Clinical data from the trial of the ClearLight device for the treatment of dermatological conditions supports substantial equivalence and demonstrates that the ClearLight device is safe and effective for the treatment of acne vulgaris.

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#### Substantial Equivalence

CureLight's ClearLight is substantially equivalent to other legally marketed Ultraviolet Dermatological Light devices. The ClearLight has the same intended use and general indications for use, and similar principles of operation and technological characteristics as the previously cleared predicate Avex Industries Ltd.'s Phototherapeutix devices; National Biological Corporation's Derma-Wand; PhotoMedex, Inc.'s XTrac Excimer Laser System, Model AL 7000; and Respironics Inc.'s Wallaby 3 Phototherapy System. In addition, the ClearLight's specific indication for use in subsumed within the general indications for use and encompassed by the specific indications for use of its predicate devices.

The ClearLight and its predicate devices are all light device that are used to treat dermatological conditions by exposing the surface of the skin to light at precise wavelengths. Although there are differences in the technological characteristics of the ClearLight and its predicate devices, those differences do not raise new questions of safety or efficacy. Thus, the ClearLight is substantially equivalent.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, arranged in a stacked formation. The profiles are black and have a flowing, abstract design. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Curclight, LTD c/o Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109

Rc: K013623

Trade/Device Name: Clearlight Phototheraphy System, Model CL 420 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: May 23, 2002 Received: May 23, 2002

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither 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 docs 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 setforth 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 S. 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" (21 CFR 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/cdrlv/dsma/dsmamain.html

Sincerely yours,

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): ____________________________________________________________________________________________________________________________________________________

Device Name: ClearLight Phototherapy Device

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number C013623

Prescription Use _ A (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use_ (Optional Format 1-2-96)