510(k) · Cleared
ClearedMobile Versa Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtek Lighting Corp · FTC Light, Ultraviolet, Dermatological
Cleared on May 25, 2012 as substantially equivalent to K050695 (Daavlin Distributing Co., 2005) and 4 other predicates after a 406-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it.
- Decided
- May 25, 2012
- Review
- 406 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K828654 (1983). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK828654 Uvb Cabinet or Goekerman Cabinet, Model Spectra 305Daavlin Co. · 1983
- 1 generation backK050695 Flex Controlled Phototherapy EquipmentDaavlin Distributing Co. · 2005
- This deviceK111049 Mobile Versa LightMedtek Lighting Corp · 2012
- Descendant · cites it directly · 0 of its ownK134009 UV Biotek Single Panel, UV Biotek Multi-DirectionalMedtek Lighting · 2014
Most influential descendants
Showing 1 of 1 · See all- K134009UV Biotek Single Panel, UV Biotek Multi-DirectionalMedtek Lighting · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K828654 | Uvb Cabinet or Goekerman Cabinet, Model Spectra 305 | Daavlin Co. | 1983 | — |
| −1 | K050695 | Flex Controlled Phototherapy Equipment | Daavlin Distributing Co. | 2005 | — |
| 0 (this device) | K111049 | Mobile Versa Light | Medtek Lighting Corp | 2012 | — |
| +1 | K134009 | UV Biotek Single Panel, UV Biotek Multi-Directional | Medtek Lighting | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K050695 | Flex Controlled Phototherapy EquipmentSummary page 2…vice(s): These devices are substantially equivalent to the following predicate devices, which are currently in safe and effective commerce: 1. K050695 - Flex Controlled Phototherapy (Daavlin) 2. K872649 - Hand/Foot UVA/UVB (National Biological) 3. K933952 -… | 2005 |
| * | K872649 | Hand/Foot Uva/Uvb 624-224Summary page 2…the following predicate devices, which are currently in safe and effective commerce: 1. K050695 - Flex Controlled Phototherapy (Daavlin) 2. K872649 - Hand/Foot UVA/UVB (National Biological) 3. K933952 - Phototherapeutix 800 (Avex, now Medtek Lighting) 4.… | 1987 |
| * | K933952 | Phototherapeutix Model 800BSummary page 2…afe and effective commerce: 1. K050695 - Flex Controlled Phototherapy (Daavlin) 2. K872649 - Hand/Foot UVA/UVB (National Biological) 3. K933952 - Phototherapeutix 800 (Avex, now Medtek Lighting) 4. K031800 - Solrx 500 Series (Solarc) 5. K904427 - Pano… | 1995 |
| * | K031800 | Solarc/Solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family a New Medical Device…Summary page 2…otherapy (Daavlin) 2. K872649 - Hand/Foot UVA/UVB (National Biological) 3. K933952 - Phototherapeutix 800 (Avex, now Medtek Lighting) 4. K031800 - Solrx 500 Series (Solarc) 5. K904427 - Panosol 11UVE- 206 (National Biological) Please see attached Predicate Compa… | 2003 |
| * | K904427 | Panosol II Uvb-206Summary page 2…ot UVA/UVB (National Biological) 3. K933952 - Phototherapeutix 800 (Avex, now Medtek Lighting) 4. K031800 - Solrx 500 Series (Solarc) 5. K904427 - Panosol 11UVE- 206 (National Biological) Please see attached Predicate Comparison Chart for detailed information. === Page 3… | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K134009 | UV Biotek Single Panel, UV Biotek Multi-Directional | 2014 | 0 |
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 22.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K134009 (Medtek Lighting, 2014) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K050695.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 UV Biotek Mobile-Lite model 600 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)
The UV Biotek Versa-Li te model 1400 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111049: Mobile Versa Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111049
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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