# K980361: Dermablate ER: Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap-Meditec North America
- Decided: Apr 21, 1998 after 82 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: 2 generations back to K954013 (1996). 3 ancestors in all.
178 later devices descend from it; 2 cite it directly.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961748: Medlite/Erbium Laser System, Continuum Biomedical, Inc. (1996) Summary page 2.
- K970934: CB Erbium/2.94(TM) ER:Yag Laser, Continuum Biomedical, Inc. (1997) Summary page 2.

## Most influential descendants
- K063571: Palomar LUX2940 Handpiece (2007), 160 descendants of its own
- K071152: Palomar Erbium Handpiece (2007), 159 descendants of its own
- K083900: Erbium Fractional Handpiece (2009), 158 descendants of its own
- K100270: Artisan Aesthetic System (2010), 157 descendants of its own
- K101506: LUX1540, LUX1440 & LUX2940 Laser Handpieces (2010), 156 descendants of its own

## Indications for use
The Dermablate laser 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).

Source page: https://510kreport.com/device/K980361
Methodology: https://510kreport.com/methodology