MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM

K041994 · Curelight, Ltd. · GEX · Oct 6, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041994
• Device Name: MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
• Applicant: Curelight, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MultiClearXL Multiwavelength Targeted Phototherapy System ("MultiClearXL") is intended to provide phototherapeutic light to the body. The MultiClearXL is generally indicated to treat dermatological conditions. The MultiClearXL's specific indication is for use in UVB phototherapy and PUVA photochemistry to treat psoriasis, vitiligo, atopic dermatitis, and leukoderma and for the use of visible blue/violet light to treat moderate inflammatory acne vulgaris.

Device Story

MultiClearXL is a computer-controlled, high-intensity lamp system for targeted dermatological phototherapy. It emits homogenous UV (UVA/UVB) and visible blue/violet light. The system comprises a console trolley, control console, illumination assembly, and an extension arm with a light guide and handpiece. Operators (clinicians) select the desired light dose via front-panel controls. The device delivers targeted light to specific skin areas to treat dermatological conditions. Protective eyewear is required for both operator and patient. The system provides a non-invasive therapeutic modality for skin disorders.

Clinical Evidence

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

Technological Characteristics

Computer-controlled high-intensity lamp system; emits homogenous UVA, UVB, and visible blue/violet light; includes console trolley, control console, illumination assembly, and extension arm with light guide/handpiece; requires protective eyewear; system operation is controlled via front panel.

Indications for Use

Indicated for patients with psoriasis, vitiligo, atopic dermatitis, leukoderma, or moderate inflammatory acne vulgaris requiring UVB phototherapy, PUVA photochemistry, or visible blue/violet light therapy.

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

• MultiClear Multiwavelength Targeted Phototherapy System (CureLight)
• ClearLight (CureLight)
• ClearTouch Acne Therapy System (Radiancy)

Submission Summary (Full Text)

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K041994 1/3

### 510(k) SUMMARY

## CURELIGHT LTD.'S MULTICLEARXL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM

# 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 011-972-4610-0969 Phone: Facsimile: 011-972-4626-0733

Contact Person: Yoram Harth, M.D.

Date Prepared: July 15, 2004

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

MultiClearXL Multiwavelength Targeted Phototherapy System CureLight Ltd. 2 Ha'ilan Street Northern Industrial Zone, POB 247 Or Akiva 30600, Israel

## Common or Usual Name

Phototherapy System

#### Classification Name

Ultraviolet Lamp for Dermatologic Disorders

#### Predicate Devices

| Device Name: | Manufacturer: |
|------------------------------------------------------------|---------------|
| MultiClear Multiwavelength Targeted<br>Phototherapy System | CureLight |
| ClearLight | CureLight |
| ClearTouch Acne Therapy System | Radiancy |

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041994 4/3

#### Intended Use / Indications for Use

The MultiClearXL Multiwavelength Targeted Phototherapy System ("MultiClearXL") is intended to provide phototherapeutic light to the body. The MultiClearXL is generally indicated to treat dermatological conditions. The MultiClearXL's specific indication is for use in UVB phototherapy and PUVA photochemistry to treat psoriasis, vitiligo, atopic dermatitis, and leukoderma and for the use of visible blue/violet light to treat moderate inflammatory acne vulgaris.

#### Technological Characteristics

The MultiClearXL is a computer controlled, high-intensity lamp intended for treatment of dermatological disorders by emitting a homogenous UV light dose in the UVB, UVA, and visible blue/violet light ranges. The desired dose of UVA or UVB or blue/violet light is selected using controls on the system front panel. The system consists of a console trolley, control console, illumination assembly, an extension arm (light guide and hand piece) and protective eyewear for the operator and patient.

## Substantial Equivalence

The MultiClearXL has the same intended use and indications and similar principles of operation and technological characteristics as a combination of the predicate devices. The MultiClearXL's specific indications

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041994 3/3

are specific indications for at least one of the predicate devices. Any minor differences between the MultiClearXL and its predicate devices raise no new issues of safety or effectiveness. Thus, the MultiClearXL is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. The text is arranged in a circular fashion, following the curve of the circle.

OCT 6 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CureLight Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson 555 Thirteenth Street NW Washington, D.C. 20004

Re: K041994

Trade/Device Name: MultiClearXL Multiwavelength Targeted Phototherapy System 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: July 23, 2004 Received: July 23, 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 for too barrow io 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) I mis lotter will and in your of substantial equivalence of your device to a legally premated predicated. " ce 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 other Ecturers, 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,

Muriam 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 Statement

2041994 510(k) Number (if known):___

Device Name: MultiClearXL Multiwavelength Targeted Phototherapy System Indications for Use:

The MultiClearXL Multiwavelength Targeted Phototherapy System ("MultiClearXL") is intended to provide phototherapeutic light to the body. The MultiClearXL is generally indicated to treat dermatological conditions. The MultiClearXL's specific indication is for use in UVB phototherapy and PUVA photochemistry to treat psoriasis, vitiligo, atopic dermatitis, and leukoderma and for the use of visible blue/violet light to treat moderate inflammatory acne vulgaris.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mirians C. Phovost (Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K041994

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