510(k) · Cleared
ClearedOmnilux Revive and Omnilux Plus
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 Aug 9, 2005 as substantially equivalent to K030426 (Photo Therapeutics Limited, 2003) and 1 other predicate after a 190-day review. Its family tree reaches back 9 generations to 1995. 160 later devices descend from it.
- Decided
- Aug 9, 2005
- Review
- 190 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K943450 (1995). 89 ancestors in all, the oldest K800617 (1980). 160 later devices descend from it, 6 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 deviceK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- Descendant · cites it directly · 115 of its ownK060792 IllumimedPhotoactif, LLC · 2006
- Descendant · cites it directly · 91 of its ownK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- Descendant · cites it directly · 91 of its ownK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
- Descendant · 2 generations on · 76 of its ownK111286 Quasar CalypsoSilver Bay, LLC · 2012
- Descendant · 3 generations on · 75 of its ownK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 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 deviceK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
Showing 5 of 160 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 160 · See all- K060792IllumimedPhotoactif, LLC · 2006 · cites it directly115descendants
- K083183Aklarus Phototherapy SystemHill Laboratories Co. · 2009 · cites it directly91descendants
- K072459Omnilux New-UPhoto Therapeutics, Inc. · 2008 · cites it directly91descendants
- K111286Quasar CalypsoSilver Bay, LLC · 2012 · 2 generations on76descendants
- K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017 · 3 generations on75descendants
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) | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| +1 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| +1 | K083183 | Aklarus Phototherapy System | Hill Laboratories Co. | 2009 | — |
| +1 | K072459 | Omnilux New-U | Photo Therapeutics, Inc. | 2008 | — |
| +2 | K111286 | Quasar Calypso | Silver Bay, LLC | 2012 | — |
| +3 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 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 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 9 | 0 |
| 2022 | 10 | 0 |
| 2023 | 13 | 0 |
| 2024 | 15 | 0 |
| 2025 | 44 | 0 |
| 2026 | 24 | 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? (2)
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 2…ge 2 === PHOTO THERRPEUTICS LTD 3- Predicate Devices Predicate devices for the Omnilux Revive and the Omnilux Plus were detailed in K030426 and 510K submission K043317 respectively. 4. Devicc Dcscription The Omnitux Revive and Omnilux Plus are two sources of h… | 2003 |
| * | K043317 | Omnilux Plus Cleared while this submission was under review Summary page 2…THERRPEUTICS LTD 3- Predicate Devices Predicate devices for the Omnilux Revive and the Omnilux Plus were detailed in K030426 and 510K submission K043317 respectively. 4. Devicc Dcscription The Omnitux Revive and Omnilux Plus are two sources of high spectral purity. Th… | 2005 |
What descends from it? (160)
See all 1606 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 9 months on median.
- 3 of the 89 ancestors have a recall of any class.
- Of its descendants, K060792 (Photoactif, LLC, 2006) has gone furthest, with 115 descendants of its own.
- 18 other devices also cite its predicate K030426.
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 Omnilux Plus Combination is intended to emit energy in the red and infra-red 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/K050216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050216: Omnilux Revive and Omnilux Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050216
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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