# K994116: Laser System Mediostar H (with and Without Skin Cooling System)

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap-Meditec North America
- Decided: Jun 1, 2000 after 178 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: 5 generations back to K963094 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982940: Lightsheer Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1999) Summary page 1.
- K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration), Laserscope (1999) Summary page 1.
- K984601: Candela Gentlelase II Dermatological Laser, Candela Corp. (1999) Summary page 1.

## Indications for use
The laser system MeDioStar H (with and without skin cooling system) is intended to remove unwanted body hair and vascular lesions. The laser system MeDioStar H is restricted to sale to or use by licensed professionals in the United States.

Source page: https://510kreport.com/device/K994116
Methodology: https://510kreport.com/methodology