# K080374: Biosyag Medical System

- Pathway: 510(k) (Traditional)
- Applicant: Bios S.R.L.
- Decided: May 15, 2008 after 93 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: 10 generations back to K910422 (1992). 157 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043521: Biosyag 50 Med, Bios S.R.L. (2005) Summary page 1.
- K072344: Apl Medical System, Bios S.R.L. (2007) Summary page 1.

## Most influential descendants
- 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 MEDICAL SYSTEM is a modular multi-laser and multi-use device for the cosmetic treatment of face and body. It is used to treat common imperfections and lesions of skin and body, including: 1. The removal of unwanted hair and to effect stable long term or permanent hair reduction, 2. Laser skin treatment procedures for the treatment of: * acne scars · wrinkles 3. Incision, excision, ablation, vaporisation of soft tissue, 4. The non-ablative treatment of facial wrinkles, such as, but not limited to: * periocular wrinkles · perioral wrinkles 5. Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions. 6. Treatment of capillaries, teleangiectasies and vascular lesions. 7. Treatment of vitiligo and psoriasis. The correlation between type of light source, wavelength, and intended use is outlined in the table displayed on the following page. The equipment should only be used under medical supervision.

Source page: https://510kreport.com/device/K080374
Methodology: https://510kreport.com/methodology