# K090762: LEDA

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Derma GmbH
- Decided: Aug 28, 2009 after 158 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 222 ancestors in all.
46 later devices descend from it; 6 cite it directly.
0 of 269 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031425: Gentlewaves Led Photomodulation Device, Light Bioscience, LLC (2004) Summary page 2.
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 2.
- K051259: Versaclear Skin Therapy System, Model 100, Theralight, Inc. (2005) Summary page 2.
- K973324: Starlight Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1997) Summary page 2.
- K982940: Lightsheer Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1999) Summary page 2.
- K001746: Lightsheer Pulsed Diode Array Laser System (Family of Products), Coherent Star (2000) Summary page 2.
- K072034: Diode Medical Laser Family, Models 4, 6, 30, Quanta System Spa (2007) Summary page 2.
- K040384: Mydon C, Wavelight Laser Technologie AG (2004) Summary page 2.

## Most influential descendants
- K200104: Oxylight (2020), 24 descendants of its own
- K240089: Face Patches (MT-12MA, MT-12MC) (2024), 16 descendants of its own
- K222751: LED Light Therapy Device, KN-7000L (2023), 11 descendants of its own
- K150752: GME ExSys 308 (2015), 9 descendants of its own
- K241293: LED Light Therapy Device, ELIXIR MD™ (2024), 7 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K090762
Methodology: https://510kreport.com/methodology