510(k) · Cleared
ClearedResolve Uvb Phototherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allux Medical · FTC Light, Ultraviolet, Dermatological
Cleared on Oct 16, 2007 as substantially equivalent to K020591 (Lumenis, 2002) and 3 other predicates after an 83-day review. Its family tree reaches back 4 generations to 1989. 6 later devices descend from it.
- Decided
- Oct 16, 2007
- Review
- 83 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K885026 (1989). 17 ancestors in all, the oldest K883779 (1988). 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 3 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- 2 generations backK020591 BclearLumenis · 2002
- 1 generation backK022165 Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc. · 2002
- This deviceK072035 Resolve Uvb Phototherapy SystemAllux Medical · 2007
- Descendant · cites it directly · 5 of its ownK170489 Skylit Phototherapy SystemSkylit Medical · 2017
- Descendant · 2 generations on · 3 of its ownK173436 Luma Light SystemLuma Therapeutics · 2018
- Descendant · 3 generations on · 2 of its ownK192642 308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020
- Descendant · 4 generations on · 1 of its ownK200971 308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK253871 Klär Lite (RCW-KL1000)Radcliffe Watts, LLC · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170489Skylit Phototherapy SystemSkylit Medical · 2017 · cites it directly5descendants
- K173436Luma Light SystemLuma Therapeutics · 2018 · 2 generations on3descendants
- K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020 · 3 generations on2descendants
- K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020 · 4 generations on1descendant
- K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −3 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| −2 | K020591 | Bclear | Lumenis | 2002 | — |
| −1 | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 | Theralight, Inc. | 2002 | — |
| 0 (this device) | K072035 | Resolve Uvb Phototherapy System | Allux Medical | 2007 | — |
| +1 | K170489 | Skylit Phototherapy System | Skylit Medical | 2017 | — |
| +2 | K173436 | Luma Light System | Luma Therapeutics | 2018 | — |
| +3 | K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2020 | — |
| +4 | K200971 | 308nm Excimer System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020 | — |
| +2 | K253871 | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K020591 | BclearSummary page 1…Class II CLASSIFICATION: PRODUCT CODE FTC PREDICATE Lumenis, Ltd. BclearTM UVB Phototherapy System DEVICES: (K020591) TheraLight, Inc. UVl20-2 UVA / UVB Phototherapy System (K022165)… | 2002 |
| * | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Summary page 1…M UVB Phototherapy System DEVICES: (K020591) TheraLight, Inc. UVl20-2 UVA / UVB Phototherapy System (K022165) Natus Medical, Inc. Natus®Blue Light Phototherapy Unit (K022196)… | 2002 |
| * | K022196 | Natus Blue Light Phototherapy UnitSummary page 1…/ UVB Phototherapy System (K022165) Natus Medical, Inc. Natus®Blue Light Phototherapy Unit (K022196) Respironics Inc. Bili-Tx Neonatal Phototherapy Device (K070180) Des… | 2002 |
| * | K070180 | Wallaby 4Summary page 1…ue Light Phototherapy Unit (K022196) Respironics Inc. Bili-Tx Neonatal Phototherapy Device (K070180) Description of Device: The ResolveTM UVB Phototherapy System is designed to deliver therapeutic… | 2007 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170489 | Skylit Phototherapy System | 2017 | 5 |
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 18 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K170489 (Skylit Medical, 2017) has gone furthest, with 5 descendants of its own.
- 8 other devices also cite its predicate K020591.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 ResolveTM UVB Phototherapy System is an ultraviolet light emitting medical device for localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. The ResolveTM UVB Phototherapy System is intended to be used with all Skin Types (I - VI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072035 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072035: Resolve Uvb Phototherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072035
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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