510(k) · Cleared
ClearedOmnilux CLEAR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globalmed Technologies · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Jun 24, 2021 as substantially equivalent to K160691 (Zuko, Inc., 2016) after an 86-day review. Its family tree reaches back 14 generations to 1995. 39 later devices descend from it.
- Decided
- Jun 24, 2021
- Review
- 86 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K943450 (1995). 102 ancestors in all, the oldest K800617 (1980). 39 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- 2 generations backK142246 LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015
- 1 generation backK160691 Acne Light Therapy WandZuko, Inc. · 2016
- This deviceK210948 Omnilux CLEARGlobalmed Technologies · 2021
- Descendant · cites it directly · 35 of its ownK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- Descendant · 2 generations on · 19 of its ownK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
- Descendant · 2 generations on · 16 of its ownK230293 TheraFace MaskTherabody, Inc. · 2023
- Descendant · 3 generations on · 10 of its ownK230124 LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V. · 2023
- Descendant · 4 generations on · 9 of its ownK230042 Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 8 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 7 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 6 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 5 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 4 generations backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- 3 generations backK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- 2 generations backK142246 LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015
- 1 generation backK160691 Acne Light Therapy WandZuko, Inc. · 2016
- This deviceK210948 Omnilux CLEARGlobalmed Technologies · 2021
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021 · cites it directly35descendants
- K214103Shani Darden LED light therapy maskHarpar Grace International · 2022 · 2 generations on19descendants
- K230293TheraFace MaskTherabody, Inc. · 2023 · 2 generations on16descendants
- K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V. · 2023 · 3 generations on10descendants
- K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −8 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −7 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −6 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −5 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −4 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| −3 | K131461 | Lightstim for Acne/ Lightstim for Acne Mini | Led Intellectual Properties, LLC | 2014 | — |
| −2 | K142246 | LightStim for Acne/ LightStim for Acne Mini | Led Intellectual Properties, LLC | 2015 | — |
| −1 | K160691 | Acne Light Therapy Wand | Zuko, Inc. | 2016 | — |
| 0 (this device) | K210948 | Omnilux CLEAR | Globalmed Technologies | 2021 | — |
| +1 | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | 2021 | — |
| +2 | K214103 | Shani Darden LED light therapy mask | Harpar Grace International | 2022 | — |
| +2 | K230293 | TheraFace Mask | Therabody, Inc. | 2023 | — |
| +3 | K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) | Light Tree Ventures Europe B.V. | 2023 | — |
| +4 | K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. | 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 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 20 | 0 |
| 2026 | 6 | 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 25.6 · 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? (1)
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 |
|---|---|---|---|
| * | K160691 | Acne Light Therapy WandSummary page 6…ed to treat mild to moderate acne vulgaris on the face. 5.3. Substantial Equivalence The Omnilux CLEAR mask is substantially equivalent to the Acne Light Therapy Wand (K160691). The Omnilux CLEAR Mask is predicated against the Acne Light Therapy Wand because both devices are LED phototherapy devices inte… | 2016 |
| † | K081307 | Omnilux Clear-U | 2009 |
What descends from it? (39)
See all 393 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 26 years and passes through 9 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 102 ancestors have a recall of any class.
- Of its descendants, K213184 (Mz Skin, 2021) has gone furthest, with 35 descendants of its own.
- 3 other devices also cite its predicate K160691.
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. 2021, 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 acne facemask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris on the face.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210948 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210948: Omnilux CLEAR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210948
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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