510(k) · Cleared
ClearedAnti-Wrinkle (Aging) Light, Model Aal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Led Intellectual Properties, LLC · ONE Powered Light Based Non-Laser Surgical Instrument
Cleared on Feb 4, 2010 as substantially equivalent to K062991 (Light Bioscience, LLC, 2008) and 3 other predicates after a 146-day review. Its family tree reaches back 11 generations to 1995. 11 later devices descend from it.
- Decided
- Feb 4, 2010
- Review
- 146 days
- Class
- Class II
- Product code
- ONE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K943450 (1995). 94 ancestors in all, the oldest K800617 (1980). 11 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations between
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- 1 generation backK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
- This deviceK092800 Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC · 2010
- Descendant · cites it directly · 10 of its ownK150098 LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015
- Descendant · 2 generations on · 4 of its ownK151333 LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015
- Descendant · 2 generations on · 3 of its ownK153399 LightStim Professional LED BedLed Intellectual Properties, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · 3 generations on · 1 of its ownK241947 EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 5 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 4 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- 1 generation backK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
- This deviceK092800 Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015 · cites it directly10descendants
- K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015 · 2 generations on4descendants
- K153399LightStim Professional LED BedLed Intellectual Properties, LLC · 2016 · 2 generations on3descendants
- K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · 2 generations on1descendant
- K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −10 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −5 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −4 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −3 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −2 | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| −1 | K072459 | Omnilux New-U | Photo Therapeutics, Inc. | 2008 | — |
| 0 (this device) | K092800 | Anti-Wrinkle (Aging) Light, Model Aal | Led Intellectual Properties, LLC | 2010 | — |
| +1 | K150098 | LightStim Professional 2-Panel Light | Led Intellectual Properties, LLC | 2015 | — |
| +2 | K151333 | LightStim for Pain LED Belt | Led Intellectual Properties, LLC | 2015 | — |
| +2 | K153399 | LightStim Professional LED Bed | Led Intellectual Properties, LLC | 2016 | — |
| +2 | K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| +3 | K241947 | EnergyLounger (TY-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
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 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 ONE? 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 ONE device
- #1 K250224 handLITE (TN19S)score 13.4 · 15 generations · no Class I recall
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 |
|---|---|---|---|
| * | K062991 | Gentlewaves Consumer Led Photomodulation DeviceSummary page 1…odel AAL Classification Name: Laser Instrument for General and Plastic Surgery Classification Code: ONE, Class 11 3. Predicate Devices Omnilux New-U (K062991) Light BioScience Gentlewaves Consumer LED (K072459) Omnilux Revive & Plus Combo (K050216) Emergo Group LumiPha… | 2008 |
| * | K072459 | Omnilux New-USummary page 1…eneral and Plastic Surgery Classification Code: ONE, Class 11 3. Predicate Devices Omnilux New-U (K062991) Light BioScience Gentlewaves Consumer LED (K072459) Omnilux Revive & Plus Combo (K050216) Emergo Group LumiPhase-R (K051255) 4. Device Description The Anti-Wrink… | 2008 |
| * | K050216 | Omnilux Revive and Omnilux PlusSummary page 1…tion Code: ONE, Class 11 3. Predicate Devices Omnilux New-U (K062991) Light BioScience Gentlewaves Consumer LED (K072459) Omnilux Revive & Plus Combo (K050216) Emergo Group LumiPhase-R (K051255) 4. Device Description The Anti-Wrinkle Light, Model AAL is a hand-held device co… | 2005 |
| * | K051255 | Lumiphase-RSummary page 1…ices Omnilux New-U (K062991) Light BioScience Gentlewaves Consumer LED (K072459) Omnilux Revive & Plus Combo (K050216) Emergo Group LumiPhase-R (K051255) 4. Device Description The Anti-Wrinkle Light, Model AAL is a hand-held device consisting of low intensity light emit… | 2005 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150098 | LightStim Professional 2-Panel Light | 2015 | 10 |
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 15 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 94 ancestors have a recall of any class.
- Of its descendants, K150098 (Led Intellectual Properties, LLC, 2015) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K062991.
How does its category compare?
All ONE devicesONE Powered Light Based Non-Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ONE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONE
376in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONE
No recall names ONE since 2007.
Adverse event reports per year · ONE
1in 2018
MAUDE reports naming product code ONE, 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 | 0 | — | 0 | 0 |
| 2010 | 4 | 376 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Anti-Wrinkle Light is a hand held device intended to emit energy in the visible and IR regions 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/K092800 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092800: Anti-Wrinkle (Aging) Light, Model Aal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092800
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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