510(k) · Cleared
ClearedLH-75T Phototherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lerner Medical Devices, Inc. · FTC Light, Ultraviolet, Dermatological
Cleared on Feb 26, 2009 as substantially equivalent to K022165 (Theralight, Inc., 2002) and 3 other predicates after a 42-day review. Its family tree reaches back 6 generations to 1989. 7 later devices descend from it.
- Decided
- Feb 26, 2009
- Review
- 42 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K885026 (1989). 19 ancestors in all, the oldest K885025 (1989). 7 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 5 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- 4 generations backK020591 BclearLumenis · 2002
- 3 generations backK022165 Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc. · 2002
- 2 generations backK024020 Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc. · 2003
- 1 generation backK040062 Levia Phototherapy SystemLerner Medical Devices, Inc. · 2004
- This deviceK090097 LH-75T Phototherapy SystemLerner Medical Devices, Inc. · 2009
- 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 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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 |
|---|---|---|---|---|---|
| −6 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −5 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| −4 | K020591 | Bclear | Lumenis | 2002 | — |
| −3 | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 | Theralight, Inc. | 2002 | — |
| −2 | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy System | Theralight, Inc. | 2003 | — |
| −1 | K040062 | Levia Phototherapy System | Lerner Medical Devices, Inc. | 2004 | — |
| 0 (this device) | K090097 | LH-75T Phototherapy System | Lerner Medical Devices, Inc. | 2009 | — |
| +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 |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 3 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Summary page 1…4 List of Predicate Devices: TheraLight, Inc. UV I 20-2 UVA /UVB Phototherapy System K022165, K024020, Lemner Medical Devices, Inc. Levia Photother… | 2002 |
| * | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy SystemSummary page 1…f Predicate Devices: TheraLight, Inc. UV I 20-2 UVA /UVB Phototherapy System K022165, K024020, Lemner Medical Devices, Inc. Levia Phototherapy Syste… | 2003 |
| * | K040062 | Levia Phototherapy SystemSummary page 1…0, Lemner Medical Devices, Inc. Levia Phototherapy System K040062 Daavlin Distributing Co. Dermapal with Digital Timer… | 2004 |
| * | K073587 | Dermapal with Digital TimerSummary page 1…0062 Daavlin Distributing Co. Dermapal with Digital Timer K073 587 LH-75T 510Ok Application Rev 4.doc Page 11 of 45 LH-75T510(k)Page 11 Device Descripti… | 2008 |
What descends from it? (7)
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 20 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K170489 (Skylit Medical, 2017) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K022165.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 LH-75T Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The LH-75T Phototherapy System is intended for use on all skin types (I -VI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090097: LH-75T 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/K090097
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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