# K014057: Dermastar ER:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Asclepion-Meditec AG
- Decided: Mar 8, 2002 after 88 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: 3 generations back to K954013 (1996). 4 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980361: Dermablate ER: Yag Laser System, Aesculap-Meditec North America (1998) Summary page 2.

## Cited in the summary but kept off the family tree
- K964128: MCL 29 Dermablate Erbium Laser System, Aesculap-Meditec GmbH (1997). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K032599: Medical Laser Technologies, LLC MTL Erbium:Yag Laser System (2003), 13 descendants of its own
- K110897: Cortex CO2 / ER:Yag Laser System (2011), 2 descendants of its own
- K110502: Triplex ER. Yag / ND: Yag System (2011), 2 descendants of its own
- K110304: Apex ER. Yag / Ipl System (2011), 2 descendants of its own
- K063867: Cutera ER:Ysgg Laser Handpiece (2007), 2 descendants of its own

## Indications for use
The DermaStar is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes) The laser system DermaStar is restricted to sale to or use by licensed professionals in the United States.

Source page: https://510kreport.com/device/K014057
Methodology: https://510kreport.com/methodology