SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:

K031800 · Solarc Systems, Inc. · FTC · Sep 10, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031800
• Device Name: SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:
• Applicant: Solarc Systems, Inc.
• Product Code: FTC · General, Plastic Surgery
• Decision Date: Sep 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Solarc/SolRx 500 Series is an ultraviolet phototherapy lamp unit used for the physician prescribed treatment of psoriasis, vitiligo, atopic dermatitis (eczema). It is intended for use as a spot treatment device, or as a hand & foot device. It is intended for use on all skin types. (I-VI)

Device Story

Solarc/SolRx 500 Series is a family of ultraviolet (UV) phototherapy lamp units (models 510UVB-NB through 550UVB-NB) used for dermatologic conditions. The device utilizes low-pressure mercury vapor fluorescent UV bulbs to deliver targeted phototherapy. It is designed for spot treatment or hand and foot treatment. The device is operated by the patient (layman) following physician prescription and comprehensive exposure guidelines provided in the user manual. Safety features include a keyed switchlock to prevent unauthorized use, wire bulb guards to prevent breakage, and a removable hood to minimize light leakage. The device incorporates a digital timer to control exposure duration. Clinical benefit is derived from the therapeutic application of UV light to affected skin areas to manage psoriasis, vitiligo, and eczema.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technical comparison of components, electrical ratings, and safety features against predicate devices.

Technological Characteristics

Low-pressure mercury vapor fluorescent UV bulbs; digital timer; keyed switchlock; wire bulb guards; removable hood for light leakage control. Electrical characteristics comparable to industry standards for medical devices. Manufactured per FDA GMP and ISO 13485.

Indications for Use

Indicated for physician-prescribed treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) in patients of all skin types (I-VI).

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

• National Biological Hand/Foot
• National Biological Panosol II 2 foot

Submission Summary (Full Text)

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# SEP 1 0 2003

### 510(k) Summary

| Date: | June 8,2003 |
|--------------|---------------------------------------------------------------------|
| Device Name: | Solarc / SolRx 500 Series Ultraviolet Phototherapy Lamp Unit Family |
| | A new medical device family consisting of 5 models: |
| | 510UVB-NB, 520UVB-NB, 530UVB-NB, 540UVB-NB, 550UVB-NB |
| Common Name: | Ultraviolet Phototherapy Lamp Unit |
| Applicant: | Solarc Systems Inc., 12 Parker Court, Barrie, ON, Canada L4N 2A6 |
| Contact: | Bruce Elliott, P.Eng., President Solarc Systems Inc. |
| Phone: | 705-739-8279 |
| Fax: | 705-739-9684 |

Solarc Systems Inc. declares that, to the best of its knowledge, the proposed device family has the same intended use and similar technical characteristics as predicate devices: National Biological Hand/Foot, and National Biological Panosol II 2 foot.

It can be demonstrated that the proposed device is as safe and effective as the legally marketed devices and does not raise different questions regarding safety and effectiveness than the predicate devices. This is based on the following areas of comparison between the proposed device and the referenced predicate devices:

#### Treatment Area & Anatomical Sites:

The proposed device can be used for both spot and hand & foot treatment, as can the predicate devices. The proposed device has a treatment area of approximately 2 square feet and is comparable to the predicate devices, with treatment areas of 3 to 4 square feet.

#### Ultraviolet Bulbs

The proposed device uses low pressure mercury vapor fluorescent ultraviolet bulbs that are comparable to that of the predicate devices, as are the spectral distribution and irradiance levels. The ballasts and related circuitry are also comparable.

#### Electrical Rating

The voltage, frequency, current ratings and other electrical characteristics are comparable. High voltage breakdown and current leakage specifications meet current industry and medical device standards.

#### Digital Timer

The proposed device uses a digital timer that is technically comparable to that of the predicate devices.

#### User's Manual

The User's Manual is written for the layman user and provides comprehensive exposure guidelines. It is at least as effective as the predicate devices.

510(k) Submission - Solarc/SolRx 500 Series Ultraviolet Phototherapy Lamp Unit

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## Safety Features

The proposed device has a keyed switchlock to prevent unauthorized usage, wire bulb guards to reduce the chance of bulb breakage and FDA compliant ultraviolet protective goggles; all comparable to those of the predicate device. In addition, the proposed device has a removable hood to minimize light leakage when used for hand & foot treatments.

#### Requlatory Requirements

The proposed device is designed and will be manufactured according to the FDA Good Manufacturing Practices and ISO13485. Solarc Systems Inc. is ISO 13485 certified.

End of 510(k) Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2003

Mr. Bruce Elliott, P. Eng. President Solarc Systems, Inc. 12 Parker Court Barrie, Ontario Canada L4N 2A6

Re: K031800

Trade/Device Name: Solarc/SolRx 500 Series Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: June 9, 2003 Received: June 12, 2003

Dear Mr. Elliott:

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. Bruce Elliott, P. Eng.

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

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Sincerely yours,

Miriam C. Provost

for 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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Image /page/4/Picture/0 description: The image shows the logo for Solar Arc Systems Inc. The logo features the word "SOLARC" in bold, stylized letters, with a curved line above it. Below "SOLARC" are the words "SYSTEMS INC." in a smaller, sans-serif font. The logo is black and white.

# Statement of Indications for Use

510(k) Number K031800

Device Name:

Solarc / SolRx 500 Series Ultraviolet Phototherapy Lamp Unit Family A new medical device family consisting of 5 models: 510UVB-NB, 520UVB-NB, 530UVB-NB, 540UVB-NB, 550UVB-NB

The Solarc/SolRx 500 Series is an ultraviolet phototherapy lamp unit used for the physician prescribed treatment of psoriasis, vitiligo, atopic dermatitis (eczema). It is intended for use as a spot treatment device, or as a hand & foot device. It is intended for use on all skin types. (I-VI)

Miriam C. Provost

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

510(k) Number K 031800