# K040384: Mydon C

- Pathway: 510(k) (Traditional)
- Applicant: Wavelight Laser Technologie AG
- Decided: May 14, 2004 after 87 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: 8 generations back to K910422 (1992). 96 ancestors in all.
51 later devices descend from it; 3 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 1.
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration), Laserscope (2002) Summary page 1.
- K022839: Fotona Dualis Plus ND:Yag Laser System, Fotona D.D. (2002) Summary page 1.
- K032220: Adept 1064/532 Laser, Adept Medical Concepts (2003) Summary page 1.

## Most influential descendants
- K090762: LEDA (2009), 46 descendants of its own
- 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

## Indications for use
1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins. 2. The MYDON C laser system is also indicated for the treatment of wrinkles. 3. The MYDON C is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB). 4. The MYDON C laser system is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. 5. The intended use of the integral cooling system in the MYDON C laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatuents such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

Source page: https://510kreport.com/device/K040384
Methodology: https://510kreport.com/methodology