SolRx E-Series Ultraviolet Phototherapy Lamp Unit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103204 FDA 510(k)
- FDA Product Code
- FTC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4630 FDA 510(k)
- Regulation Number
- 878.4630 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SolRx E-Series Ultraviolet Phototherapy Lamp Unit is a dermatological ultraviolet light device designed for phototherapy. It emits ultraviolet B (UVB) narrowband radiation to treat skin conditions such as psoriasis, vitiligo, and atopic dermatitis (eczema).
This wall-mounted or self-supporting unit is available in configurations with 2, 4, 6, 8, or 10 bulbs, each measuring 6 feet in height. The system can be used standalone or expanded with additional units for multidirectional light exposure. It is intended for home use and has received FDA 510(k) clearance under the General, Plastic Surgery advisory committee classification.
Frequently asked questions
What skin conditions is the SolRx E-Series Ultraviolet Phototherapy Lamp Unit designed to treat?
The SolRx E-Series is specifically designed to treat skin conditions such as psoriasis, vitiligo, and atopic dermatitis (eczema) using narrowband ultraviolet B (UVB) radiation. The device delivers targeted phototherapy to help manage these chronic dermatological conditions.
How many bulb configurations are available for the SolRx E-Series, and what are the typical use cases for each?
The SolRx E-Series is available in configurations with 2, 4, 6, 8, or 10 bulbs, each measuring 6 feet in height. Smaller configurations (2–4 bulbs) are ideal for localized treatment or smaller treatment areas, while larger setups (6–10 bulbs) allow for broader exposure or multidirectional light therapy. Units can also be combined for expanded coverage in home settings.
Is the SolRx E-Series Ultraviolet Phototherapy Lamp Unit intended for clinical or home use?
The SolRx E-Series is explicitly designed for home use, as stated in the device description. It is wall-mounted or self-supporting, making it accessible for patients to manage their phototherapy regimen outside of clinical settings.
What regulatory pathway was followed for FDA clearance of the SolRx E-Series?
The SolRx E-Series received FDA clearance through a 510(k) submission, classified under the General, Plastic Surgery advisory committee (SU). The clearance was granted as substantially equivalent (SESE) to a predicate device, following a traditional review process.
Can the SolRx E-Series be expanded for multidirectional light exposure, and if so, how?
Yes, the SolRx E-Series can be expanded for multidirectional light exposure by connecting additional units. This setup allows patients to adjust their treatment angles and coverage, accommodating varying skin exposure needs in a home environment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SolRx E-Series Full Body Phototherapy System, Solarc Systems Home UVB-NB Phototherapy Devices, Solarc / Solrx E-series Ultraviolet Phototherapy Lamp Unit Family, SolRx Home Phototherapy Device Store - solarcsystems.ca
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103204 | Class II | Active |
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Manufacturer
- Manufacturer
- Solarc Systems Inc
- FDA Applicant
- Solarc Systems, Inc.
Sources (1)
- FDA 510(k) K103204 24 fields · synced Sep 19, 2026