510(k) · Cleared
ClearedSkylit Phototherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skylit Medical · FTC Light, Ultraviolet, Dermatological
Cleared on May 23, 2017 as substantially equivalent to K040062 (Lerner Medical Devices, Inc., 2004) and 3 other predicates after a 95-day review. Its family tree reaches back 7 generations to 1989. 5 later devices descend from it.
- Decided
- May 23, 2017
- Review
- 95 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K885026 (1989). 28 ancestors in all, the oldest K883779 (1988). 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 6 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- 5 generations backK020591 BclearLumenis · 2002
- 4 generations backK022165 Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc. · 2002
- 3 generations backK024020 Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc. · 2003
- 2 generations backK040062 Levia Phototherapy SystemLerner Medical Devices, Inc. · 2004
- 1 generation backK090097 LH-75T Phototherapy SystemLerner Medical Devices, Inc. · 2009
- This deviceK170489 Skylit Phototherapy SystemSkylit Medical · 2017
- Descendant · cites it directly · 3 of its ownK173436 Luma Light SystemLuma Therapeutics · 2018
- Descendant · 2 generations on · 2 of its ownK192642 308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK200971 308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK253871 Klär Lite (RCW-KL1000)Radcliffe Watts, LLC · 2026
- Descendant · 4 generations on · 0 of its ownK242977 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4…Xuzhou Kernel Medical Equipment Co., Ltd. · 2025
Most influential descendants
Showing 5 of 5 · See all- K173436Luma Light SystemLuma Therapeutics · 2018 · cites it directly3descendants
- K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020 · 2 generations on2descendants
- K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020 · 3 generations on1descendant
- K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC · 2026 · cites it directly0descendants
- K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −6 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| −5 | K020591 | Bclear | Lumenis | 2002 | — |
| −4 | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 | Theralight, Inc. | 2002 | — |
| −3 | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy System | Theralight, Inc. | 2003 | — |
| −2 | K040062 | Levia Phototherapy System | Lerner Medical Devices, Inc. | 2004 | — |
| −1 | K090097 | LH-75T Phototherapy System | Lerner Medical Devices, Inc. | 2009 | — |
| 0 (this device) | K170489 | Skylit Phototherapy System | Skylit Medical | 2017 | — |
| +1 | K173436 | Luma Light System | Luma Therapeutics | 2018 | — |
| +2 | K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2020 | — |
| +3 | K200971 | 308nm Excimer System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020 | — |
| +1 | K253871 | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | 2026 | — |
| +4 | K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C… | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K040062 | Levia Phototherapy SystemSummary page 4…eted phototherapy, UVB treatment devices. Specifically, the Clarify Phototherapy System is substantially equivalent to the Lerner Medical Inc. Levia Phototherapy System (K040062/K090097), Daavlin Distributing Co. DermaPal (K073587) and Allux, Inc. Resolve UVB Phototherapy System (K072035). Device Descript… | 2004 |
| * | K090097 | LH-75T Phototherapy SystemSummary page 4…totherapy, UVB treatment devices. Specifically, the Clarify Phototherapy System is substantially equivalent to the Lerner Medical Inc. Levia Phototherapy System (K040062/K090097), Daavlin Distributing Co. DermaPal (K073587) and Allux, Inc. Resolve UVB Phototherapy System (K072035). Device Description The… | 2009 |
| * | K073587 | Dermapal with Digital TimerSummary page 4…y, the Clarify Phototherapy System is substantially equivalent to the Lerner Medical Inc. Levia Phototherapy System (K040062/K090097), Daavlin Distributing Co. DermaPal (K073587) and Allux, Inc. Resolve UVB Phototherapy System (K072035). Device Description The Clarify Phototherapy System is a handheld med… | 2008 |
| * | K072035 | Resolve Uvb Phototherapy SystemSummary page 4…lent to the Lerner Medical Inc. Levia Phototherapy System (K040062/K090097), Daavlin Distributing Co. DermaPal (K073587) and Allux, Inc. Resolve UVB Phototherapy System (K072035). Device Description The Clarify Phototherapy System is a handheld medical device that produces UVB light for the purpose of pho… | 2007 |
What descends from it? (5)
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?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K173436 (Luma Therapeutics, 2018) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K040062.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototheraputic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and lenkoderma on all skintypes (I-VI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170489: Skylit Phototherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170489
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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