# K030805: Mythos 500

- Pathway: 510(k) (Traditional)
- Applicant: Msq (M2), Ltd.
- Decided: May 21, 2003 after 69 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: 1 generation back to K001746 (2000). 2 ancestors in all.
363 later devices descend from it; 2 cite it directly.
0 of 366 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001746: Lightsheer Pulsed Diode Array Laser System (Family of Products), Coherent Star (2000)
- K003614: Lightsheer Pulsed Diode Array Laser System, Coherent Star (2001)

## Most influential descendants
- K041959: Polaris DS/Comet (2004), 301 descendants of its own
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene (2006), 299 descendants of its own
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), 263 descendants of its own
- K071295: 100W Ceralas D 980NM Diode Laser (2007), 230 descendants of its own
- K072106: 150W Ceralas D 980NM Diode Laser (2007), 229 descendants of its own

## Indications for use
The MYTHOS 500TM Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The MYTHOS 500TM System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Source page: https://510kreport.com/device/K030805
Methodology: https://510kreport.com/methodology