510(k) · Cleared
ClearedOmnilux Clear-U
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photo Therapeutics, Inc. · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Jan 16, 2009 as substantially equivalent to K030426 (Photo Therapeutics Limited, 2003) and 2 other predicates after a 253-day review. Its family tree reaches back 9 generations to 1995. 169 later devices descend from it.
- Decided
- Jan 16, 2009
- Review
- 253 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K943450 (1995). 86 ancestors in all, the oldest K800617 (1980). 169 later devices descend from it, 9 citing it directly.
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations between
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 1 generation backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- This deviceK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- Descendant · cites it directly · 125 of its ownK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- Descendant · cites it directly · 112 of its ownK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- Descendant · 2 generations on · 107 of its ownK140471 Pro X Otc 5La Lumiere, LLC · 2015
- Descendant · 3 generations on · 106 of its ownK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- Descendant · 4 generations on · 93 of its ownK170984 LG Beauty Led MaskLg Electronics · 2017
Show all 9 generations
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 1 generation backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- This deviceK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
Showing 5 of 169 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 169 · See all- K121435Silkn BlueHome Skinovations, Ltd. · 2013 · cites it directly125descendants
- K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013 · cites it directly112descendants
- K140471Pro X Otc 5La Lumiere, LLC · 2015 · 2 generations on107descendants
- K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017 · 3 generations on106descendants
- K170984LG Beauty Led MaskLg Electronics · 2017 · 4 generations on93descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −8 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −3 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −2 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −1 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| 0 (this device) | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| +1 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| +1 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| +2 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| +3 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| +4 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 9 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 10 | 0 |
| 2022 | 14 | 0 |
| 2023 | 16 | 0 |
| 2024 | 15 | 0 |
| 2025 | 49 | 0 |
| 2026 | 25 | 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 OLP? 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 OLP device
- #1 K214103 Shani Darden LED light therapy maskscore 25.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K030426 | Omnilux RedSummary page 1…evice is not a laser and is intended for OTC use, the manufacturer thinks this is the closest applicable classification name. 3. Predicate Devices Ormnilux Revive (K030426), Omnilux blue (K030883), Omnilux revive/Omnilux blue combination (K043329). 4. Device Description The O… | 2003 |
| * | K030883 | Omnilux BlueSummary page 1…is intended for OTC use, the manufacturer thinks this is the closest applicable classification name. 3. Predicate Devices Ormnilux Revive (K030426), Omnilux blue (K030883), Omnilux revive/Omnilux blue combination (K043329). 4. Device Description The Omnilux Clear-U is a sour… | 2003 |
| * | K043329 | Omnilux Revive and BlueSummary page 1…his is the closest applicable classification name. 3. Predicate Devices Ormnilux Revive (K030426), Omnilux blue (K030883), Omnilux revive/Omnilux blue combination (K043329). 4. Device Description The Omnilux Clear-U is a source of high spectral purity It provides uniform or "… | 2005 |
What descends from it? (169)
See all 1699 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 14 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 3 of the 86 ancestors have a recall of any class.
- Of its descendants, K121435 (Home Skinovations, Ltd., 2013) has gone furthest, with 125 descendants of its own.
- 18 other devices also cite its predicate K030426.
How does its category compare?
All OLP devicesOLP Over-The-Counter Powered Light Based Laser For Acne: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OLP
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLP
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLP
1in 2025
MAUDE reports naming product code OLP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 245 | 0 | 0 |
| 2014 | 3 | 255 | 0 | 1 |
| 2015 | 3 | 159 | 0 | 0 |
| 2016 | 6 | 99 | 0 | 1 |
| 2017 | 4 | 151 | 4 | 1 |
| 2018 | 5 | 104 | 0 | 7 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 6 | 260 | 0 | 7 |
| 2022 | 5 | 245 | 0 | 1 |
| 2023 | 3 | 109 | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 3 | 88 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081307 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081307: Omnilux Clear-U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081307
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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