510(k) · Cleared
ClearedSolarc/Solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family a New Medical Device Family Consisting of 5 Models:
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 Sep 10, 2003 after a 91-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Sep 10, 2003
- Review
- 91 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK031800 Solarc/Solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family a…Solarc Systems, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK111049 Mobile Versa LightMedtek Lighting Corp · 2012
- Descendant · 2 generations on · 0 of its ownK134009 UV Biotek Single Panel, UV Biotek Multi-DirectionalMedtek Lighting · 2014
- Descendant · cites it directly · 0 of its ownK103204 Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit FamilySolarc Systems, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- K111049Mobile Versa LightMedtek Lighting Corp · 2012 · cites it directly1descendant
- K134009UV Biotek Single Panel, UV Biotek Multi-DirectionalMedtek Lighting · 2014 · 2 generations on0descendants
- K103204Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit FamilySolarc Systems, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031800 | Solarc/Solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family a New… | Solarc Systems, Inc. | 2003 | — |
| +1 | K111049 | Mobile Versa Light | Medtek Lighting Corp | 2012 | — |
| +2 | K134009 | UV Biotek Single Panel, UV Biotek Multi-Directional | Medtek Lighting | 2014 | — |
| +1 | K103204 | Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit Family | Solarc Systems, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | — | National Biological Hand/Foot Named without a submission number | |
| * | — | National Biological Panosol II 2 foot Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K111049 (Medtek Lighting Corp, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Solar/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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031800: Solarc/Solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family a New Medical Device Family Consisting of 5 Models:.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031800
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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