# K993815: Uni-Laser 430

- Pathway: 510(k) (Traditional)
- Applicant: Medart Corp.
- Decided: May 11, 2000 after 183 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
- K080104: Vari-Lase Endovenous Laser Console, Model 7542 (2008), 0 descendants of its own

## Indications for use
The Uni-Laser™ 430 is intended for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels) In contact mode the Uni-Laser 430 can be used for vaporization, ablation, incision, and excision of soft tissue.

Source page: https://510kreport.com/device/K993815
Methodology: https://510kreport.com/methodology