510(k) · Cleared
ClearedLEDA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Derma GmbH · GEX Powered Laser Surgical Instrument
Cleared on Aug 28, 2009 as substantially equivalent to K031425 (Light Bioscience, LLC, 2004) and 7 other predicates after a 158-day review. Its family tree reaches back 15 generations to 1995. 46 later devices descend from it.
- Decided
- Aug 28, 2009
- Review
- 158 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 15 generations to K943450 (1995). 222 ancestors in all, the oldest K800617 (1980). 46 later devices descend from it, 6 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 2 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 1 generation backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- This deviceK090762 LEDAQuantel Derma GmbH · 2009
- Descendant · cites it directly · 24 of its ownK200104 OxylightRaja Trading Company, Inc. · 2020
- Descendant · 2 generations on · 16 of its ownK240089 Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- Descendant · 2 generations on · 11 of its ownK222751 LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023
- Descendant · cites it directly · 9 of its ownK150752 GME ExSys 308Gme (German Medical Engineering) GmbH · 2015
- Descendant · 3 generations on · 7 of its ownK241293 LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC · 2024
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 2 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 1 generation backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- This deviceK090762 LEDAQuantel Derma GmbH · 2009
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K200104OxylightRaja Trading Company, Inc. · 2020 · cites it directly24descendants
- K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · 2 generations on16descendants
- K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023 · 2 generations on11descendants
- K150752GME ExSys 308Gme (German Medical Engineering) GmbH · 2015 · cites it directly9descendants
- K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC · 2024 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −2 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −1 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| 0 (this device) | K090762 | LEDA | Quantel Derma GmbH | 2009 | — |
| +1 | K200104 | Oxylight | Raja Trading Company, Inc. | 2020 | — |
| +2 | K240089 | Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
| +2 | K222751 | LED Light Therapy Device, KN-7000L | Xuzhou Kernel Medical Equipment Co., Ltd. | 2023 | — |
| +1 | K150752 | GME ExSys 308 | Gme (German Medical Engineering) GmbH | 2015 | — |
| +3 | K241293 | LED Light Therapy Device, ELIXIR MD™ | Yassen Wellness, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 10 | 0 |
| 1995 | 13 | 0 |
| 1996 | 17 | 0 |
| 1997 | 21 | 0 |
| 1998 | 11 | 0 |
| 1999 | 8 | 0 |
| 2000 | 19 | 0 |
| 2001 | 22 | 0 |
| 2002 | 27 | 0 |
| 2003 | 17 | 0 |
| 2004 | 11 | 0 |
| 2005 | 7 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 15 | 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 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? (8)
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 2…cs as the following predicate devices: * For LEDA applicator SCR 585 yellow: o GentleWaves LED Light Photomodulation Device (K031425) manufactured by BioScience L.L.C. * For LEDA applicator SCR 635 red: o Omnilux Revive (K030426) ma… | 2004 |
| * | K030426 | Omnilux RedSummary page 2…t Photomodulation Device (K031425) manufactured by BioScience L.L.C. * For LEDA applicator SCR 635 red: o Omnilux Revive (K030426) manufactured by Photo Therapeutics Inc. o VersaClear (K051259) manufactured by TheraLight… | 2003 |
| * | K051259 | Versaclear Skin Therapy System, Model 100Summary page 2…For LEDA applicator SCR 635 red: o Omnilux Revive (K030426) manufactured by Photo Therapeutics Inc. o VersaClear (K051259) manufactured by TheraLight Inc. Summary: The LEDA LED applicators, SCR 585 yellow and SCR 635 red, are… | 2005 |
| * | K973324 | Starlight Pulsed Diode Array Laser SystemSummary page 2…nge: 4 mW/cm 2 up to 120 mW/cm 2. Dose range: 0.1 J/cm 2 up to 100 J/cm * For LEDA applicators EPI 808 and EPI 980: o LightSheer (K973324, K982940, K001746) manufactured by Lumenis (formerly Star Medical / Coherent Star) o Quanta Sys… | 1997 |
| * | K982940 | Lightsheer Pulsed Diode Array Laser SystemSummary page 2…/cm 2 up to 120 mW/cm 2. Dose range: 0.1 J/cm 2 up to 100 J/cm * For LEDA applicators EPI 808 and EPI 980: o LightSheer (K973324, K982940, K001746) manufactured by Lumenis (formerly Star Medical / Coherent Star) o Quanta System's Dio… | 1999 |
| * | K001746 | Lightsheer Pulsed Diode Array Laser System (Family of Products)Summary page 2…to 120 mW/cm 2. Dose range: 0.1 J/cm 2 up to 100 J/cm * For LEDA applicators EPI 808 and EPI 980: o LightSheer (K973324, K982940, K001746) manufactured by Lumenis (formerly Star Medical / Coherent Star) o Quanta System's Diode Medica… | 2000 |
| * | K072034 | Diode Medical Laser Family, Models 4, 6, 30Summary page 2…973324, K982940, K001746) manufactured by Lumenis (formerly Star Medical / Coherent Star) o Quanta System's Diode Medical Laser Family (K072034) manufactured by Quanta System SpA o MYDON (K040384) manufactured by Quantel Derma… | 2007 |
| * | K040384 | Mydon CSummary page 2…ical / Coherent Star) o Quanta System's Diode Medical Laser Family (K072034) manufactured by Quanta System SpA o MYDON (K040384) manufactured by Quantel Derma GmbH (formerly Wavelight) Summary: The LEDA LED applicators EPI 808… | 2004 |
What descends from it? (46)
See all 466 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 14 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 10 of the 222 ancestors have a recall of any class.
- Of its descendants, K200104 (Raja Trading Company, Inc., 2020) has gone furthest, with 24 descendants of its own.
- 5 other devices also cite its predicate K031425.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 LEDA System with the Applicator LEDA SCR 585 yellow is indicated for the treatment of periorbital wrinkles and rhytides.
The LEDA System with the Applicator LEDA SCR 635 red is indicated for the treatment of superficial, benign vascular, and pigmented lesions.
The LEDA System with the Applicators LEDA EPI 808 and LEDA EPI 980 is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090762: LEDA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090762
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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