# K231948: Mediyag

- Pathway: 510(k) (Special)
- Applicant: Medicreations, LLC
- Decided: Oct 9, 2024 after 467 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: 16 generations back to K943450 (1995). 261 ancestors in all.
No later device cites it as a predicate yet.
0 of 262 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161926: ND YAG Q-switch Laser Therapy Machine, Beijing Adss Development Co., Ltd. (2017) Summary page 7.
- K193477: Nd: YAG Laser Therapy Systems, Beijing Kes Biology Technology Co., Ltd. (2020) Summary page 7.

## Indications for use
The MediYag is indicated for: 532nm wavelength: treatment of benign pigmented lesions (Lentigines, Birthmark; Cafe-Au-Lait). 1064nm wavelength: treatment of acne scars, benign pigmented lesions (Nevus, Nevus of Ota), and removal of dark ink tattoos (black, blue).

Source page: https://510kreport.com/device/K231948
Methodology: https://510kreport.com/methodology