510(k) · Cleared
ClearedOmnilux Red
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 Jul 17, 2003 as substantially equivalent to K020839 (Lumenis, Inc., 2002) and 2 other predicates after a 157-day review. Its family tree reaches back 8 generations to 1995. 563 later devices descend from it.
- Decided
- Jul 17, 2003
- Review
- 157 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K943450 (1995). 82 ancestors in all, the oldest K800617 (1980). 563 later devices descend from it, 19 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 deviceK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- Descendant · cites it directly · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 3 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · cites it directly · 169 of its ownK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- Descendant · cites it directly · 160 of its ownK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
Showing 5 of 563 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 563 · See all- K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · cites it directly402descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 3 generations on198descendants
- K081307Omnilux Clear-UPhoto Therapeutics, Inc. · 2009 · cites it directly169descendants
- K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005 · cites it directly160descendants
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) | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| +1 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| +2 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +3 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +1 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| +1 | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 14 | 0 |
| 2009 | 8 | 0 |
| 2010 | 13 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 11 | 0 |
| 2014 | 18 | 0 |
| 2015 | 26 | 0 |
| 2016 | 23 | 0 |
| 2017 | 35 | 0 |
| 2018 | 30 | 0 |
| 2019 | 23 | 0 |
| 2020 | 32 | 0 |
| 2021 | 33 | 0 |
| 2022 | 46 | 0 |
| 2023 | 40 | 0 |
| 2024 | 53 | 0 |
| 2025 | 85 | 0 |
| 2026 | 51 | 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? (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 |
|---|---|---|---|
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 1…The Omnilux Revive is substantially equivalent to a combination of the following devices: the IPL Quantum SR manufactured by Lumenis, Inc. and subject of K020839; the Aurora SR manufactured by Syneron Medical Ltd. and subject of K022266; and the EsteLux manufactured by Palomar Medica… | 2002 |
| * | K022266 | Aurora SRSummary page 1…devices: the IPL Quantum SR manufactured by Lumenis, Inc. and subject of K020839; the Aurora SR manufactured by Syneron Medical Ltd. and subject of K022266; and the EsteLux manufactured by Palomar Medical Technologies, Inc. and subject of K020453. 4. Device Description… | 2002 |
| * | K020453 | Palomar Estelux Pulsed Light System and Palomar CoolrollerSummary page 1…he Aurora SR manufactured by Syneron Medical Ltd. and subject of K022266; and the EsteLux manufactured by Palomar Medical Technologies, Inc. and subject of K020453. 4. Device Description The Omnilux Revive is an intense visible light source of high spectral purity. It pro… | 2002 |
What descends from it? (563)
See all 56319 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042630 | Revlight Skin Care System | 2005 | 402 |
| K081307 | Omnilux Clear-U | 2009 | 169 |
| K050216 | Omnilux Revive and Omnilux Plus | 2005 | 160 |
| K051255 | Lumiphase-R | 2005 | 143 |
| K060792 | Illumimed | 2006 | 115 |
| K072459 | Omnilux New-U | 2008 | 91 |
| K051259 | Versaclear Skin Therapy System, Model 100 | 2005 | 47 |
| K090762 | LEDA | 2009 | 46 |
| K200104 | Oxylight | 2020 | 24 |
| K120460 | Smartlux | 2012 | 18 |
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 8 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 3 of the 82 ancestors have a recall of any class.
- Of its descendants, K042630 (Skincare Technology, Inc., 2005) has gone furthest, with 402 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 Revive is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030426: Omnilux Red.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030426
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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