PSORIA-LIGHT

K103540 · Psoria-Shield, Inc. · FTC · Feb 10, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103540
• Device Name: PSORIA-LIGHT
• Applicant: Psoria-Shield, Inc.
• Product Code: FTC · General, Plastic Surgery
• Decision Date: Feb 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Psoria-Light Model PS1000 is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.

Device Story

Psoria-Light Model PS1000 delivers targeted UVA (350-395nm) or UVB (300-320nm) light to small skin regions (2.88 cm) while sparing healthy tissue. Device utilizes LED technology, eliminating mercury/xenon/chlorine gas lamps. Handpiece includes non-contact sensor to detect skin surface; UV dosage trigger mechanism remains disabled until skin contact is confirmed. Used by clinicians for targeted phototherapy. Output allows precise treatment of dermatologic conditions. Benefits include localized delivery, reduced exposure to healthy skin, and avoidance of hazardous gas-based light sources.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the device's similarity to previously cleared predicate devices for the same indications for use. Bench testing and certification to international standards (IEC 60601 series, UL 60601-1, FCC Part 15, EN55011) and risk management (ISO 14971) were performed.

Technological Characteristics

Targeted UV phototherapy system using UVA (350-395nm) and UVB (300-320nm) LEDs. Features non-contact skin sensor for safety interlock. Conforms to IEC 60601-1, IEC 60601-1-2, UL 60601-1, and 21 CFR 1040.10. Complies with FCC Part 15 and EN55011 for EMC. Risk management per ISO 14971.

Indications for Use

Indicated for patients with psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma requiring targeted PUVA or UVB phototherapy.

Regulatory Classification

Identification

An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.

Predicate Devices

• TheraLight Inc. DuaLight UV120-2 UVA/UVB Phototherapy System (K024020)
• PhotoMedex, Inc. XTRAC Ultra2 Excimer Laser System, Model AL10000 (K073659)

Submission Summary (Full Text)

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K103540

FEB 10 20il

# ENCLOSURE E

Non-Confidential 510(k) Summary of Safety and Effectiveness

Psoria-Shield Inc. 6408 W. Linebaugh Avenue Suite 104 Tampa, FL 33625

| Official Contact: | Scot Johnson<br>Chief Technology Officer |
|---------------------|--------------------------------------------------------------------------------------|
| Trade/Device Name: | Psoria-Light Model PS1000 |
| Device Common Name: | Targeted UVA / UVB Phototherapy System |
| Regulation Number: | 878.4630 |
| Regulation Name: | Ultraviolet lamp for dermatologic disorders |
| Regulatory Class: | Class II |
| Product Code: | FTC |
| Predicate Devices: | This product is substantially equivalent in design,<br>composition, and function to: |
| | TheraLight Inc.<br>DuaLight UV120-2 UVA/UVB Phototherapy System<br>K024020 |
| | PhotoMedex, Inc.<br>XTRAC Ultra2 Excimer Laser System, Model AL10000<br>K073659 |

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K103540

pg 2 of 3

# ENCLOSURE E

## Non-Confidential 510(k) Summary of Safety and Effectiveness

## Device Description:

Psoria-Light™ Model PS1000 delivers targeted ultraviolet (UV) light to small regions of affected skin (2.88 cm), sparring healthy skin. The system is capable of delivering either UVB light (300 to 320nm) or UVA light (350 to 395nm). Psoria-Light™ Model PS1000 generates both UVA and UVB light via LED technology, avoiding environmental concerns associated with disposal and exchange of mercury gas lamps, Xenon, and Chlorine gases commonly associated with targeted UV phototherapy devices. Psoria-Light's™ UVB LEDs emit light between 300 and 320 nm, avoiding light emissions below 300nm.

Psoria-Light™ Model PS1000 incorporates a unique safety feature, a non-contact sensor located about the aperture of the handpiece that detects human skin. The trigger mechanism for UV dosage administration (located on the handpiece) is disabled until a suitable surface is detected by this sensor.

## Labeling and Instructions for Use:

See Proposed Labeling and Instructions for Use in sections J and Q respectively.

#### Intended Use:

The Psoria-Light Model PS1000 is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.

## Substantial Equivalence:

The characteristics of the Psoria-Shield Psoria-Light Model PS1000 are substantially equivalent to those of the predicate devices. Operation of the predicate devices, including output wavelengths, power, and light sources have received 510(k) clearance previously for these type of treatments.

#### Clinical Performance Testing:

All clinical indications requested in this application have been previously cleared in the identified predicate devices. The Psoria-Light Model PS1000 does not introduce any new indications for use, and will perform in a substantially equivalent manner as the identified predicates. Therefore Psoria-Shield believes duplicative clinical data is not required as a condition of granting market clearance for the Psoria-Light Model PS1000.

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K103540

pg 3 of 3

# ENCLOSURE E

## Non-Confidential 510(k) Summary of Safety and Effectiveness

### Product Performance Testing:

Testing and certification relevant to the Psoria-Light Model PS1000 includes conformance to current applicable international IEC 60601 series of standards, 21 CFR Part 1040.10, Performance Standard for Light-Emitting Products and certification to the UL 60601-1 Medical Electrical Equipment classification standard. Product will also comply with EMC (Electromagnetic Compatibility) requirements per FCC rules part 15, IEC 60601-1-2 and its particular Standards for susceptibility and emissions, as well as EN55011. The Psoria-Light Model PS1000 has been reviewed for risk management utilizing ISO 14971, Application of risk management to medical devices ensuring all aspects of the device are reviewed for potential hazards.

The Psoria-Light Model PS1000 shall have completed all testing to the standards and procedures identified in this submission prior to any product being released for sale. Products shall be produced and distributed by a facility that has been registered with the FDA to manufacture medical devices.

### Conclusions:

The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is Substantially Equivalent to the predicate devices and it does not introduce any new issues of safety or efficacy. The Indications for Use and methods of operation are substantially equivalent to the predicates for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and of leukoderma.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Psoria-Shield. Inc. % Technireg, Inc. Mr. Wayne Glover 19404 Pine Valley Drive Odessa, Florida 33556

FEB 10 201

Re: K103540

Trade/Device Name: Psoria-Light Model PS 1000 Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: November 30, 2010 Received: December 02, 2010

Dear Mr. Glover:

and the comments of the comments of the comments of

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, Orug, 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 Ice 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

a participal production in the lineral in

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Page 2 – Mr. Wayne Glover

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

A.S. B. R. h
for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# ENCLOSURE D

# INDICATIONS FOR USE

K103540

510(k) Number (if known):

Device Name:

Psoria-Light Model PS1000

Indications for Use:

The Psoria-Light Model PS1000 is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.

Prescription Use X (Per 21 CFR 801 Subpart D) and/or

Over-the-counter use (Per 21 CFR 801 Subpart C)

PJ

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103540