510(k) · Cleared
ClearedLH-75 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 Nov 5, 2009 as substantially equivalent to K022165 (Theralight, Inc., 2002) and 4 other predicates after a 156-day review. Its family tree reaches back 7 generations to 1989.
- Decided
- Nov 5, 2009
- Review
- 156 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K885026 (1989). 24 ancestors in all, the oldest K828654 (1983). No later device cites it as a predicate yet.
- 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 deviceK091568 LH-75 Phototherapy SystemLerner Medical Devices, Inc. · 2009
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) | K091568 | LH-75 Phototherapy System | Lerner Medical Devices, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 3 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 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? (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 |
|---|---|---|---|
| * | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Summary page 1…TheraLight, Inc. UVI 20-2 UVA / UVB Phototherapy System K022165, K024020, Lerner Medical Devices, Inc.… | 2002 |
| * | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy SystemSummary page 1…TheraLight, Inc. UVI 20-2 UVA / UVB Phototherapy System K022165, K024020, Lerner Medical Devices, Inc. LH-… | 2003 |
| * | K090097 | LH-75T Phototherapy SystemSummary page 1…Lerner Medical Devices, Inc. LH-75T Phototherapy System K090097 Daavlin Distributing Co. 3 Series… | 2009 |
| * | K063621 | 3 Series Phototherapy CabinetSummary page 1…Daavlin Distributing Co. 3 Series Phototherapy Cabinet K063621 Daavlin Distributing Co. Flex Con… | 2007 |
| * | K050695 | Flex Controlled Phototherapy EquipmentSummary page 1…Daavlin Distributing Co. Flex Controlled Phototherapy Equipment K050695 D1-00057-05 LH-75 510k Application 052709.doc Page 11 of 46 LH-75 510(k) Page 11… | 2005 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 24 ancestors has a recall.
- 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-75 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-75 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/K091568 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091568: LH-75 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/K091568
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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