# K984339: Medart 455 Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Del Mar Technologies, Inc.
- Decided: Feb 18, 1999 after 76 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K073048: Peterio Universal Laser Scanning Handpiece (2008), 0 descendants of its own

## Indications for use
The MedArt® 455/910-series Scanner will be used to manipulate and place a pulsed and/or CW beam for use in Dermatology for treatment of any soft tissue, including ablation, vaperization or coagulation of soft tissue.

Source page: https://510kreport.com/device/K984339
Methodology: https://510kreport.com/methodology