510(k) · Cleared
ClearedGentlewaves Consumer Led Photomodulation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Bioscience, LLC · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Feb 15, 2008 as substantially equivalent to K031425 (Light Bioscience, LLC, 2004) after a 504-day review. Its family tree reaches back 1 generation to 2004. 22 later devices descend from it.
- Decided
- Feb 15, 2008
- Review
- 504 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031425 (2004). 22 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK031425 Gentlewaves Led Photomodulation DeviceLight Bioscience, LLC · 2004
- This deviceK062991 Gentlewaves Consumer Led Photomodulation DeviceLight Bioscience, LLC · 2008
- Descendant · cites it directly · 11 of its ownK092800 Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC · 2010
- Descendant · 2 generations on · 10 of its ownK150098 LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015
- Descendant · cites it directly · 9 of its ownK090525 Loi SystemPalomar Medical Products, Inc. · 2009
- Descendant · 3 generations on · 4 of its ownK151333 LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015
- Descendant · 3 generations on · 3 of its ownK153399 LightStim Professional LED BedLed Intellectual Properties, LLC · 2016
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC · 2010 · cites it directly11descendants
- K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015 · 2 generations on10descendants
- K090525Loi SystemPalomar Medical Products, Inc. · 2009 · cites it directly9descendants
- K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015 · 3 generations on4descendants
- K153399LightStim Professional LED BedLed Intellectual Properties, LLC · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031425 | Gentlewaves Led Photomodulation Device | Light Bioscience, LLC | 2004 | — |
| 0 (this device) | K062991 | Gentlewaves Consumer Led Photomodulation Device | Light Bioscience, LLC | 2008 | — |
| +1 | K092800 | Anti-Wrinkle (Aging) Light, Model Aal | Led Intellectual Properties, LLC | 2010 | — |
| +2 | K150098 | LightStim Professional 2-Panel Light | Led Intellectual Properties, LLC | 2015 | — |
| +1 | K090525 | Loi System | Palomar Medical Products, Inc. | 2009 | — |
| +3 | K151333 | LightStim for Pain LED Belt | Led Intellectual Properties, LLC | 2015 | — |
| +3 | K153399 | LightStim Professional LED Bed | Led Intellectual Properties, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 4 | 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 OHS? 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 OHS device
- #1 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 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 |
|---|---|---|---|
| * | K031425 | Gentlewaves Led Photomodulation DeviceSummary page 1…ating Classification Name Surgical powered laser instrument Predicate Devices Light BioScience, LLC's GentleWaves LED Photomodulation System (K031425) 1 \\C- 0241311000001 - 2362383 vi Intended Use I Indic… | 2004 |
What descends from it? (22)
See all 222 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?
How does its category compare?
All OHS devicesOHS Light Based Over The Counter Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OHS
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHS
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHS
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHS
34in 2025
MAUDE reports naming product code OHS, 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 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 176 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 4 | 310 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 168 | 0 | 1 |
| 2015 | 4 | 241 | 0 | 0 |
| 2016 | 3 | 191 | 0 | 0 |
| 2017 | 8 | 133 | 0 | 1 |
| 2018 | 7 | 84 | 0 | 1 |
| 2019 | 4 | 99 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 7 | 162 | 0 | 2 |
| 2022 | 16 | 129 | 0 | 2 |
| 2023 | 12 | 101 | 0 | 4 |
| 2024 | 16 | 87 | 0 | 5 |
| 2025 | 42 | 89 | 0 | 34 |
| 2026 | 26 | 88 | 0 | — |
What is it indicated for?
The GentleWaves Consumer LED Photomodulation Device is intended/indicated for over-the-counter use in the treatment of periorbital wrinkles and rhytides.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062991: Gentlewaves Consumer Led Photomodulation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062991
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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