510(k) · Cleared
ClearedKlär Lite (RCW-KL1000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radcliffe Watts, LLC · FTC Light, Ultraviolet, Dermatological
Cleared on Mar 4, 2026 as substantially equivalent to K170489 (Skylit Medical, 2017) after a 90-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Mar 4, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K885026 (1989). 29 ancestors in all, the oldest K883779 (1988). No later device cites it as a predicate yet.
- Root · 8 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 7 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- 6 generations backK020591 BclearLumenis · 2002
- 5 generations backK022165 Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc. · 2002
- 4 generations backK024020 Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc. · 2003
- 3 generations backK040062 Levia Phototherapy SystemLerner Medical Devices, Inc. · 2004
- 2 generations backK090097 LH-75T Phototherapy SystemLerner Medical Devices, Inc. · 2009
- 1 generation backK170489 Skylit Phototherapy SystemSkylit Medical · 2017
- This deviceK253871 Klär Lite (RCW-KL1000)Radcliffe Watts, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −7 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| −6 | K020591 | Bclear | Lumenis | 2002 | — |
| −5 | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 | Theralight, Inc. | 2002 | — |
| −4 | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy System | Theralight, Inc. | 2003 | — |
| −3 | K040062 | Levia Phototherapy System | Lerner Medical Devices, Inc. | 2004 | — |
| −2 | K090097 | LH-75T Phototherapy System | Lerner Medical Devices, Inc. | 2009 | — |
| −1 | K170489 | Skylit Phototherapy System | Skylit Medical | 2017 | — |
| 0 (this device) | 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 |
| 1990 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K170489 | Skylit Phototherapy SystemSummary page 7…=== Feature Predicate Device – Skylit Subject Device – Klär Comparison Phototherapy System Lite Result (K170489) K253871 Technology Narrowband UV-B LED Narrowband UV-B Identical Type photo… | 2017 |
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?
- The line of descent spans 37 years and passes through 7 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 29 ancestors has a recall of any class.
- 1 other device also cites its predicate K170489.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Klar Lite is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (1-VI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253871 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253871: Klär Lite (RCW-KL1000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253871
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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