# K043521: Biosyag 50 Med

- Pathway: 510(k) (Traditional)
- Applicant: Bios S.R.L.
- Decided: Mar 24, 2005 after 94 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 K020107 (2002). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020107: Smartepil, Cynosure, Inc. (2002) Summary page 1.

## Most influential descendants
- K080374: Biosyag Medical System (2008), 2 descendants of its own
- K113018: Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based Platform (2012), 1 descendant of its own
- K221766: Solon (2024), 0 descendants of its own

## Indications for use
The BIOSYAG 50 Med laser is indicated for benign vascular lesions and hair removal. The equipment should only be used under medical supervision.

Source page: https://510kreport.com/device/K043521
Methodology: https://510kreport.com/methodology