(91 days)
National Biological Hand/Foot, National Biological Panosol II 2 foot
Not Found
No
The 510(k) summary describes a phototherapy lamp with a digital timer and safety features, with no mention of AI or ML capabilities.
Yes
The device is described as an "ultraviolet phototherapy lamp unit used for the physician prescribed treatment of psoriasis, vitiligo, atopic dermatitis (eczema)," indicating its intended use for therapeutic purposes.
No
The device is described as an ultraviolet phototherapy lamp unit used for treatment, not for diagnosing conditions.
No
The device description clearly outlines hardware components such as ultraviolet bulbs, a digital timer, a keyed switchlock, wire bulb guards, goggles, and a removable hood.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Solarc/SolRx 500 Series is a phototherapy lamp unit that applies ultraviolet light directly to the patient's skin for treatment. It does not involve the analysis of any bodily specimens.
The device description clearly indicates it's a therapeutic device used for treating skin conditions, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for 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)
Product codes (comma separated list FDA assigned to the subject device)
FTC
Device Description
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 proposed device uses low pressure mercury vapor fluorescent ultraviolet bulbs. It has a digital timer, keyed switchlock, wire bulb guards, FDA compliant ultraviolet protective goggles, and a removable hood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spot and hand & foot treatment
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician prescribed treatment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
National Biological Hand/Foot, National Biological Panosol II 2 foot
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
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.(b)
Classification. Class II.
0
031800 ""
Image /page/0/Picture/1 description: The image shows the logo for Solar Arc Systems Inc. The word "SOLARC" is written in a bold, sans-serif font, with a curved line above it. Below "SOLARC" is the text "SYSTEMS INC." in a smaller, sans-serif font. The logo is in black and white.
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
Page 13
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K 031800 4/2
Image /page/1/Picture/1 description: The image shows the logo for Solar Arc Systems Inc. The logo features the word "SOLARC" in bold, sans-serif font, with a curved line extending from the bottom left of the "S" and arching over the top of the word. Below "SOLARC" and slightly to the right, the words "SYSTEMS INC." are printed in a smaller, sans-serif font.
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
€
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