510(k) · Cleared
ClearedFotona Skinlight Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Laser Solutions · GEX Powered Laser Surgical Instrument
Cleared on Jan 10, 1997 as substantially equivalent to K953585 (Schwartz Electro-Optics, Inc., 1996) after a 169-day review. Its family tree reaches back 1 generation to 1996. 63 later devices descend from it.
- Decided
- Jan 10, 1997
- Review
- 169 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953585 (1996). 63 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK953585 Schwartz Electro-Optices, Inc. Trilase 2100/20 Holmium LaserSchwartz Electro-Optics, Inc. · 1996
- This deviceK962902 Fotona Skinlight Laser SystemMedical Laser Solutions · 1997
- Descendant · cites it directly · 58 of its ownK971648 Sharplan Erbium: Yag Laser (4020)Sharplan Lasers, Inc. · 1997
- Descendant · 2 generations on · 56 of its ownK981438 Dornier Medilas EDornier Surgical Products, Inc. · 1998
- Descendant · 3 generations on · 53 of its ownK050317 Burane XLWavelight Laser Technologie AG · 2005
- Descendant · 3 generations on · 52 of its ownK052806 BuraneWavelight Laser Technologie AG · 2005
- Descendant · 4 generations on · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K971648Sharplan Erbium: Yag Laser (4020)Sharplan Lasers, Inc. · 1997 · cites it directly58descendants
- K981438Dornier Medilas EDornier Surgical Products, Inc. · 1998 · 2 generations on56descendants
- K050317Burane XLWavelight Laser Technologie AG · 2005 · 3 generations on53descendants
- K052806BuraneWavelight Laser Technologie AG · 2005 · 3 generations on52descendants
- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 4 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953585 | Schwartz Electro-Optices, Inc. Trilase 2100/20 Holmium Laser | Schwartz Electro-Optics, Inc. | 1996 | — |
| 0 (this device) | K962902 | Fotona Skinlight Laser System | Medical Laser Solutions | 1997 | — |
| +1 | K971648 | Sharplan Erbium: Yag Laser (4020) | Sharplan Lasers, Inc. | 1997 | — |
| +2 | K981438 | Dornier Medilas E | Dornier Surgical Products, Inc. | 1998 | — |
| +3 | K050317 | Burane XL | Wavelight Laser Technologie AG | 2005 | — |
| +3 | K052806 | Burane | Wavelight Laser Technologie AG | 2005 | — |
| +4 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2005 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K953585 | Schwartz Electro-Optices, Inc. Trilase 2100/20 Holmium LaserSummary page 1…he user. Summary of Substantial Equivalence Fotona believes that its Skinlight system is substantially equivalent to the Schwartz Electro-Optics ( SEO ) TriLase 2940 ( K 953585). The TriLase 2940 is cleared for the cutting, vaporization, and coagulation of soft tissue. It therefore has the same Intended… | 1996 |
What descends from it? (63)
See all 634 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?
- Its one ancestor has no recall.
- Of its descendants, K971648 (Sharplan Lasers, Inc., 1997) has gone furthest, with 58 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 laser is intended to be used for cutting, vaporizing, and coagulating soft tissue.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962902: Fotona Skinlight Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962902
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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