# K103204: Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit Family

- Pathway: 510(k) (Traditional)
- Applicant: Solarc Systems, Inc.
- Decided: Apr 27, 2011 after 177 days
- Product code: FTC (Light, Ultraviolet, Dermatological)
- Device class: 2
- Regulation: 21 CFR 878.4630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K827890 (1982). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935572: Solarc 1000 Series Ultraviolet Phototherapy Lamp Unit, Solarc Systems, Inc. (1994) Summary page 1.
- K031800: Solarc/Solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family a New Medical Device Family Consisting of 5 Models:, Solarc Systems, Inc. (2003) Summary page 1.
- K061589: Solarc / Solrx Handheld Ultraviolet Phototherapy Lamp Unit Family, Solarc Systems, Inc. (2006) Summary page 1.
- K854498: Spectra 724, Daavlin Co. (1985) Summary page 1.
- K827890: Foldalite Unit, National Biological Corp. (1982) Summary page 1.
- (no number) National Biological Corp. (NBC) "Panosol 3D": named in the summary without a submission number
- (no number) National Biological Corp. "Panosol 11... with optional wings": named in the summary without a submission number

## Indications for use
The Solarc/SoIRx E-Series Ultraviolet Phototherapy Lamp Family is a wall-mounted or self-supporting ultraviolet phototherapy lamp unit used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use as a spot or full-body treatment device. It is intended for use on all skin types. (I -VI) This device is intended for Prescriptive Use only, per Part 21 CFR 801 Subpart 0.

Source page: https://510kreport.com/device/K103204
Methodology: https://510kreport.com/methodology