510(k) · Cleared
ClearedOmnilux Revive and Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photo Therapeutics Limited · GEX Powered Laser Surgical Instrument
Cleared on Mar 18, 2005 as substantially equivalent to K020839 (Lumenis, Inc., 2002) and 3 other predicates after a 106-day review. Its family tree reaches back 8 generations to 1995. 202 later devices descend from it.
- Decided
- Mar 18, 2005
- Review
- 106 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K943450 (1995). 83 ancestors in all, the oldest K800617 (1980). 202 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 3 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 2 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 1 generation backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- This deviceK043329 Omnilux Revive and BluePhoto Therapeutics Limited · 2005
- Descendant · cites it directly · 169 of its ownK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- Descendant · 2 generations on · 125 of its ownK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- Descendant · 2 generations on · 112 of its ownK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- Descendant · 3 generations on · 107 of its ownK140471 Pro X Otc 5La Lumiere, LLC · 2015
- Descendant · 4 generations on · 106 of its ownK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
Showing 5 of 202 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 202 · See all- K081307Omnilux Clear-UPhoto Therapeutics, Inc. · 2009 · cites it directly169descendants
- K121435Silkn BlueHome Skinovations, Ltd. · 2013 · 2 generations on125descendants
- K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013 · 2 generations on112descendants
- K140471Pro X Otc 5La Lumiere, LLC · 2015 · 3 generations on107descendants
- K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017 · 4 generations on106descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −7 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −3 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −2 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −1 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| 0 (this device) | K043329 | Omnilux Revive and Blue | Photo Therapeutics Limited | 2005 | — |
| +1 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| +2 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| +2 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| +3 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| +4 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 15 | 0 |
| 2023 | 19 | 0 |
| 2024 | 18 | 0 |
| 2025 | 52 | 0 |
| 2026 | 26 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 1…but the predicates are listed below for completeness. Omnilux Revive is substantially equivalent to ... IPL Quantum SR manufactured by Lumenis, Inc. (K020839) Aurora SR manufactured by Syneron Medical Ltd.(K022266) EsteLux manufactured by Palomar Medical Technologies,… | 2002 |
| * | K022266 | Aurora SRSummary page 1…Omnilux Revive is substantially equivalent to ... IPL Quantum SR manufactured by Lumenis, Inc. (K020839) Aurora SR manufactured by Syneron Medical Ltd.(K022266) EsteLux manufactured by Palomar Medical Technologies, Inc. (K020453)… | 2002 |
| * | K020453 | Palomar Estelux Pulsed Light System and Palomar CoolrollerSummary page 1…factured by Lumenis, Inc. (K020839) Aurora SR manufactured by Syneron Medical Ltd.(K022266) EsteLux manufactured by Palomar Medical Technologies, Inc. (K020453) 00 0)t… | 2002 |
| * | K013623 | Clearlight Phototheraphy System, Model CL 420Summary page 2…$ c C at2 Ormnlux Blue is substantially equivalent to.. Lumnenis ClearLight (K013623). 4. Device Description of two sources of high spectral The Omnilux Revi… | 2002 |
What descends from it? (202)
See all 2023 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 10 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 83 ancestors have a recall of any class.
- Of its descendants, K081307 (Photo Therapeutics, Inc., 2009) has gone furthest, with 169 descendants of its own.
- 20 other devices also cite its predicate K020839.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Omnilux Revive and Blue Combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043329 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043329: Omnilux Revive and Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043329
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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