CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002

K041569 · Curelight, Ltd. · GEX · Jun 30, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041569
• Device Name: CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002
• Applicant: Curelight, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Clear100™ Phototherapy System (" Clear100™ ") is intended to provide phototherapeutic light to the body. The Clear100 ™ is indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris and infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

Device Story

Clear100 Phototherapy System provides phototherapeutic light to body. Device emits visible blue/violet light (405-420 nm) for moderate inflammatory acne vulgaris and near-infrared light (850-890 nm) for temporary increase in local blood circulation, relief of minor muscle/joint aches, pains, stiffness, and muscle spasms. System comprises high-intensity lamp, optical system for spectral/beam control, mechanical fixture for adjustable positioning, and timer unit. Operated by healthcare provider in clinical setting. Provider positions device relative to skin treatment area and sets duration via timer. Output is light energy (50-200 mW/cm2) applied to skin. Benefits include non-invasive management of acne and temporary musculoskeletal pain relief.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-intensity lamp emitting visible violet-blue (405-420 nm) and near-infrared (850-890 nm) light. Fluency: 50-200 mW/cm2. Includes optical system for spectral/beam control, mechanical fixture for adjustable positioning, and timer unit. No software or connectivity described.

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris (blue/violet light treatment) and patients requiring temporary increase in local blood circulation, relief of minor muscle/joint aches, pains, stiffness, muscle relaxation, or relief of muscle spasms and arthritis-associated pain (infrared light treatment).

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 ReClear™

Submission Summary (Full Text)

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JUN 3 0 2004

K041569

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# 510(k) SUMMARY

#### CureLight's Clear100

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

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

Contact Person: Dr. Yoram Harth

Date Prepared: May 18th, 2004

## Name of Device and Name/Address of Sponsor

Clear100™ 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 ReClear™

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#### 2/2 Ko41569

#### Intended Use

The Clear100™ Phototherapy System (" Clear100™ ") is intended to provide phototherapeutic light to the body. The Clear100 ™ is indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris and infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

#### Technological Characteristics

The Clear100™ Therapy System is a high intensity lamp emitting visible light in the violet-blue range (405 nm to 420 nm) and in the near infrared range (850-890nm) with a 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 near infrared range with 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 a timer unit to indicate the duration of light treatment.

#### Substantial Equivalence

The Clear100™ has the same intended use and indications for use and very similar technological characteristics as the CureLight ReClear. The minor technological differences between these devices, i.e., the number of lamps they contain and the type of timer, do not raise any new questions of safety or effectiveness. Thus, Clear100™ is substantially equivalent to its predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its body and wings. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 3 0 2004

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

Re: K041569

Trade/Device Name: Clear 100™ Phototherapy System Regulation Number: 21 CFR 878.4810, 21 CFR 890.5500 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology; Infrared lamp Regulatory Class: II Product Code: GEX, ILY Dated: June 10, 2004 Received: June 10, 2004

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 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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html

Sincerely yours,

Miriam 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

K041569 510(k) Number:

Device Name:

Clear100™ Phototherapy System

Indications for Use:

The Clear100™ Phototherapy System (" Clear100™ ") is intended to provide phototherapeutic light to the body. The Clear100 ™ is indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris and infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

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

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 2003)

Muriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________