# K120573: Medart 620

- Pathway: 510(k) (Special)
- Applicant: Medart A/S
- Decided: Jun 13, 2012 after 107 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Dermatology, Plastic & General Surgery The C02 laser, model MedArt 620, is intended to be used by physicians in the performance of the following specialties: 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 Cantraindi!catians for MedArt® 620 The MedArt® 620 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/K120573
Methodology: https://510kreport.com/methodology