# K083123: Medart Model 610 CO2 Laser System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Medart A/S
- Decided: Nov 24, 2009 after 398 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 K991297 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991297: Uni-Laser 450P CO2 Laser System & Accessories, Medart Corp. (1999) Summary page 1.

## Indications for use
Dermatology, Plastic & General Surgery The C02 laser, model MedArt 610, is intended to be used by physicians in the performance of the following specialities: The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of: * Skin Resurfacing * Treatment of wrinkles and rhytids * Treatment of furrows * Soft tissue ablation Contraindications for MedArt® 610 The MedArt® 610 may not be used for hard tissue dental applications such as tooth enamel, dentin or fillings and other indications not cleared by the FDA. The system has not been evaluated for safety and effectiveness as a fractionated scanner

Source page: https://510kreport.com/device/K083123
Methodology: https://510kreport.com/methodology