VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100

K051259 · Theralight, Inc. · GEX · Sep 20, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051259
• Device Name: VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
• Applicant: Theralight, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VersaClear System is intended to provide phototherapeutic light to the body. The VersaClear is generally indicated to treat dermatological conditions. Blue light modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light for the treatment of moderate inflammatory acne vulgaris, and for use alone in the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

Device Story

VersaClear Skin Therapy System is a phototherapeutic illumination source; provides narrow-spectrum light via interchangeable blue (420nm), red (615nm), or UVA (368nm) modules. Modules mount on positioning arms attached to mobile/stationary pedestals, walls, or countertops. Used in clinical office settings by healthcare providers to treat patients in sitting, reclining, or lying positions. Device delivers light energy to skin; clinical effect depends on specific wavelength and indication (acne, vascular/pigmented lesions, or skin disorders). Healthcare providers select appropriate module based on patient condition; output facilitates dermatological treatment. Benefits include non-invasive management of specified skin conditions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

120/240V 50/60 Hz AC illumination source. Interchangeable light modules: blue (420 ± 2nm), red (615 ± 3nm), UVA (368 ± 3nm). Mounted on positioning arms with mobile/stationary pedestal, wall, or countertop configurations. Non-software based; mechanical/electrical light delivery system.

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris (blue light or blue/red combination), superficial benign vascular and pigmented lesions (red light), or diagnosed skin disorders requiring ultraviolet radiation therapy (UVA light).

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

• Blu-U Photodynamic Therapy Illuminator (K031805)
• Omnilux Blue (K030883)
• Omnilux Red (K030426)
• Omnilux Revive and Blue (K043329)
• HOUVA II UVA (K885025)
• HOUVA 3 Phototherapy System (K041212)
• UV 1000 (K841795)

Submission Summary (Full Text)

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## SEP 2 0 2005

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# 510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

| Submitter's name: | TheraLight, Inc. | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter's Address: | 2794 Loker Avenue West, Suite 105<br>Carlsbad, CA 92008 | |
| Telephone: | [phone] | |
| Contact: | Kevin E. Daly<br>Chief Operating Officer | |
| Date Prepared: | May 13, 2005 | |
| Device Trade Name: | VersaClear™ Skin Therapy System | |
| Device Common Name: | VersaClear™ Skin Therapy System | |
| Device Classification Name: | Laser surgical instrument for use in general and<br>plastic surgery and in dermatology (ref. 21 CFR<br>878.4810); Ultraviolet lamp for dermatologic / skin<br>disorders (ref. 21 CFR 878.4630). | |
| Predicate Devices: | Blu-U Photodynamic Therapy Illuminator<br>Dusa Pharmaceuticals, Inc.<br>K031805 | |
| | Omnilux Blue<br>Photo Therapeutics, Ltd.<br>K030883 | |
| | Omnilux Red<br>Photo Therapeutics, Ltd.<br>K030426 | |
| | Omnilux Revive and Blue<br>Photo Therapeutics, Ltd.<br>K043329 | |
| | HOUVA II UVA<br>National Biological Corporation<br>K885025 | |
| | HOUVA 3 Phototherapy System<br>National Biological Corporation<br>K041212 | |
| Predicate Devices (cont'd): | UV 1000 | |
| | Waldmann Lichttechnik | |
| | K841795 | |

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#### Device Description:

The VersaClear™ Skin Therapy System is a 120/240V 50/60 Hz AC illumination source consisting of one or more light modules. A set of light modules emits a specific narrow spectrum of light, namely blue (420 ± 2nm), red (615 ± 3nm), or UVA (368 ± 3nm). The light modules are mounted on a positioning arm attached to a mobile or stationary pedestal, a wall, or a countertop. This flexible design accommodates varying office spatial settings, and allows for the treatment of patients who are sitting, reclining, or lying down. Light modules are interchangeable to maximize System versatility.

#### Intended Use and Indications for Use:

The VersaClear System is intended to provide phototherapeutic light to the body. The VersaClear is generally indicated to treat dermatological conditions. Blue light modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light for the treatment of moderate inflammatory acne vulgaris, and for use alone in the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

#### Performance Data:

The performance characteristics of the VersaClear System are substantially similar to the cited predicate devices. The technological differences do not raise new types of safety or efficacy issues. On this basis, the VersaClear System is substantially equivalent to the predicate devices.

#### Conclusion:

On the basis of the information provided in this Summary, TheraLight believes that the VersaClear Skin Therapy System is substantially equivalent to legally commercialized predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and head. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2005

Mr. Kevin E. Daly Chief Operating Officer TheraLight, Inc. 2794 Loker Avenue West, Suite 105 Carlsbad, California 92008-6616

Re: K051259 Trade/Device Name: VersaClear™ Skin Therapy 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, FTC Dated: September 2, 2005 Received: September 6, 2005

Dear Mr. Daly:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection o re(t) possession is substantially equivalent (for the indications felerenced above and nave decembers and marketed predicate devices marketed in interstate for use stated in the encrosate) to regard as a many and call be vice Amendments, or to commerce prior to May 20, 1976, the exactions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosmetic Ac. (710t) that do not require to the general controls provisions of the Act. The 1 ou may, merelore, manel the Act include requirements for annual registration, listing of general controls provisions of tactice, 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 If your device is classified (500 as roy als. Existing major regulations affecting your device can may be subject to sublications, 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 r least be advised that I Dris issualles syour device complies with other requirements of the Act that I Drehan statutes and regulations administered by other Federal agencies. You must or any I coolar statutes and submitted to: registration and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 007, adoling (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic fordling the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2- Mr. Kevin E. Daly

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,

Barbara Budrin

Mark N. Melkerson Acting 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

510(k) Number (if known): K051259

Device Name: VersaClear™ Skin Therapy System

Indications for Use:

The VersaClear Skin Therapy System is generally indicated to treat dermatological The Versachour Dimi- modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light modules vulgaris. Technique of moderate inflammatory acne vulgaris, and for use alone the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated of superietar, beling in vasoa.ca, are ultraviolet radiation therapy for diagnosed skin disorders.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

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

Chabala Buchup for MKM

Division of Ge neral. Restorative. and Neurological De

510(k) Number.

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