510(k) · Cleared
ClearedGentlewaves Led Photomodulation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Bioscience, LLC · GEX Powered Laser Surgical Instrument
Cleared on Dec 15, 2004 after a 590-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 199 later devices descend from it.
- Decided
- Dec 15, 2004
- Review
- 590 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
199 later devices descend from it, 6 citing it directly.
- This deviceK031425 Gentlewaves Led Photomodulation DeviceLight Bioscience, LLC · 2004
- Descendant · cites it directly · 143 of its ownK051255 Lumiphase-ROpusmed, Inc. · 2005
- Descendant · cites it directly · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- Descendant · 2 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Showing 5 of 199 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 199 · See all- K051255Lumiphase-ROpusmed, Inc. · 2005 · cites it directly143descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · cites it directly129descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 2 generations on112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031425 | Gentlewaves Led Photomodulation Device | Light Bioscience, LLC | 2004 | — |
| +1 | K051255 | Lumiphase-R | Opusmed, Inc. | 2005 | — |
| +1 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +2 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +3 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 11 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 11 | 0 |
| 2019 | 9 | 0 |
| 2020 | 15 | 0 |
| 2021 | 11 | 0 |
| 2022 | 20 | 0 |
| 2023 | 14 | 0 |
| 2024 | 19 | 0 |
| 2025 | 32 | 0 |
| 2026 | 18 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (199)
See all 1996 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?
- Of its descendants, K051255 (Opusmed, Inc., 2005) has gone furthest, with 143 descendants of its own.
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 GentleWaves LED Photomodulation Device is indicated/intended for use in the treatment of periorbital wrinkles and rhytides.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K031425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031425: Gentlewaves 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/K031425
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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