510(k) · Cleared
ClearedSolarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solarc Systems, Inc. · FTC Light, Ultraviolet, Dermatological
Cleared on Apr 27, 2011 as substantially equivalent to K935572 (Solarc Systems, Inc., 1994) and 4 other predicates after a 177-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Apr 27, 2011
- Review
- 177 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K827890 (1982). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK827890 Foldalite UnitNational Biological Corp. · 1982
- This deviceK103204 Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit FamilySolarc Systems, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K827890 | Foldalite Unit | National Biological Corp. | 1982 | — |
| 0 (this device) | K103204 | Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit Family | Solarc Systems, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FTC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTC device
- #1 K242977 308nm Excimer Phototherapy Device (CN-308E…score 14.8 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K935572 | Solarc 1000 Series Ultraviolet Phototherapy Lamp UnitSummary page 1…the proposed device family has the same intended use and similar technical characteristics as the following predicate devices: Solarc/SolRx 1000 Series [51 0(k)# K935572] Solarc/SoIRx 500 Series [510(k)# K031800] Solarc/SolRx 100 Series [51 0(k)#: K061589] Daavlin "7-Series" an… | 1994 |
| * | K031800 | Solarc/Solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family a New Medical Device…Summary page 1…use and similar technical characteristics as the following predicate devices: Solarc/SolRx 1000 Series [51 0(k)# K935572] Solarc/SoIRx 500 Series [510(k)# K031800] Solarc/SolRx 100 Series [51 0(k)#: K061589] Daavlin "7-Series" and "2-Series" [510(k)# K854498 "Spectra 724"]… | 2003 |
| * | K061589 | Solarc / Solrx Handheld Ultraviolet Phototherapy Lamp Unit FamilySummary page 1…ollowing predicate devices: Solarc/SolRx 1000 Series [51 0(k)# K935572] Solarc/SoIRx 500 Series [510(k)# K031800] Solarc/SolRx 100 Series [51 0(k)#: K061589] Daavlin "7-Series" and "2-Series" [510(k)# K854498 "Spectra 724"] National Biological Corp. (NBC) "Foldalite-32" [… | 2006 |
| * | K854498 | Spectra 724Summary page 1…[51 0(k)# K935572] Solarc/SoIRx 500 Series [510(k)# K031800] Solarc/SolRx 100 Series [51 0(k)#: K061589] Daavlin "7-Series" and "2-Series" [510(k)# K854498 "Spectra 724"] National Biological Corp. (NBC) "Foldalite-32" [510(k)#: K827890] National Biological Corp. (NBC) "P… | 1985 |
| * | K827890 | Foldalite UnitSummary page 1…x 100 Series [51 0(k)#: K061589] Daavlin "7-Series" and "2-Series" [510(k)# K854498 "Spectra 724"] National Biological Corp. (NBC) "Foldalite-32" [510(k)#: K827890] National Biological Corp. (NBC) "Panosol 3D" [510(k)#: uncertain] National Biological Corp. "Panosol 11... with op… | 1982 |
| * | — | National Biological Corp. (NBC) "Panosol 3D" Named without a submission number | |
| * | — | National Biological Corp. "Panosol 11... with optional wings" Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 5 ancestors has a recall.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FTC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTC
76in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTC
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTC
8in 2025
MAUDE reports naming product code FTC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 53 | 0 | 0 |
| 2008 | 3 | 41 | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 5 | 125 | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 98 | 0 | 8 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 3 | 88 | 0 | 0 |
| 2019 | 2 | — | 0 | 14 |
| 2020 | 5 | 237 | 0 | 4 |
| 2021 | 3 | 89 | 0 | 48 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 4 | 48 | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 76 | 1 | 8 |
| 2026 | 4 | 91 | 3 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103204: Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103204
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026