510(k) · Cleared
ClearedOmnilux New-U
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photo Therapeutics, Inc. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Mar 3, 2008 as substantially equivalent to K030426 (Photo Therapeutics Limited, 2003) and 2 other predicates after a 185-day review. Its family tree reaches back 10 generations to 1995. 91 later devices descend from it.
- Decided
- Mar 3, 2008
- Review
- 185 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K943450 (1995). 90 ancestors in all, the oldest K800617 (1980). 91 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations between
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- This deviceK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
- Descendant · cites it directly · 66 of its ownK110301 Silk'n FXHome Skinovations, Ltd. · 2011
- Descendant · 2 generations on · 61 of its ownK152332 Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity · 2016
- Descendant · 3 generations on · 55 of its ownK162489 RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 2017
- Descendant · 4 generations on · 42 of its ownK212155 TheraFace LEDTheragun, Inc. · 2021
- Descendant · 4 generations on · 39 of its ownK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
Show all 10 generations
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 4 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- This deviceK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K110301Silk'n FXHome Skinovations, Ltd. · 2011 · cites it directly66descendants
- K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity · 2016 · 2 generations on61descendants
- K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 2017 · 3 generations on55descendants
- K212155TheraFace LEDTheragun, Inc. · 2021 · 4 generations on42descendants
- K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023 · 4 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −9 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −4 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −3 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −2 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −1 | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| 0 (this device) | K072459 | Omnilux New-U | Photo Therapeutics, Inc. | 2008 | — |
| +1 | K110301 | Silk'n FX | Home Skinovations, Ltd. | 2011 | — |
| +2 | K152332 | Perfectio LED infrared device | Omm Imports Inc Dba Zero Gravity | 2016 | — |
| +3 | K162489 | RED Light Device | Zhongshan Bisen Plastic Electronic Products Co., Ltd. | 2017 | — |
| +4 | K212155 | TheraFace LED | Theragun, Inc. | 2021 | — |
| +4 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 | — |
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 | 10 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 34 | 0 |
| 2026 | 18 | 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 OHS? 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 OHS device
- #1 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 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…device is not a laser and is intended for OTC use, the manufacturer thinks this is the closest applicable classification name. 3. Predicate Devices Omnilux Revive (K030426), Omnilux plus (K0433 17), Omnilux revive/Omnilux plus combination (K0502t16). 4. Device Description The… | 2003 |
| * | K043317 | Omnilux PlusSummary page 1…nd is intended for OTC use, the manufacturer thinks this is the closest applicable classification name. 3. Predicate Devices Omnilux Revive (K030426), Omnilux plus (K0433 17), Omnilux revive/Omnilux plus combination (K0502t16). 4. Device Description The Omnilux New-U is a sourc… | 2005 |
| * | K050216 | Omnilux Revive and Omnilux PlusSummary page 2…believes that no significant differences exist between the previously approved Omnilux revive (K030426), Omnilux plus (K043317), Omnilux revive/Omnilux plus combination (K050216) and the Omnilux New-U. Therefore, the Omnilux New-U raises no new issues of safety or effectiveness.… | 2005 |
What descends from it? (91)
See all 916 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 13 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 90 ancestors have a recall of any class.
- Of its descendants, K110301 (Home Skinovations, Ltd., 2011) has gone furthest, with 66 descendants of its own.
- 18 other devices also cite its predicate K030426.
How does its category compare?
All OHS devicesOHS Light Based Over The Counter Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OHS
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHS
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHS
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHS
34in 2025
MAUDE reports naming product code OHS, 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 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 176 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 4 | 310 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 168 | 0 | 1 |
| 2015 | 4 | 241 | 0 | 0 |
| 2016 | 3 | 191 | 0 | 0 |
| 2017 | 8 | 133 | 0 | 1 |
| 2018 | 7 | 84 | 0 | 1 |
| 2019 | 4 | 99 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 7 | 162 | 0 | 2 |
| 2022 | 16 | 129 | 0 | 2 |
| 2023 | 12 | 101 | 0 | 4 |
| 2024 | 16 | 87 | 0 | 5 |
| 2025 | 42 | 89 | 0 | 34 |
| 2026 | 26 | 88 | 0 | — |
What is it indicated for?
The Omnilux New-U is intended to emit energy in the red and IR region of the spectrum
for use in dermatology for the treatment of periorbital wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072459 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072459: Omnilux New-U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072459
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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