# K964128: MCL 29 Dermablate Erbium Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap-Meditec GmbH
- Decided: Mar 17, 1997 after 153 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). 2 ancestors in all.
67 later devices descend from it; 6 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954013: Trilase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. (1996) Summary page 3.
- K961748: Medlite/Erbium Laser System, Continuum Biomedical, Inc. (1996) Summary page 3.

## Most influential descendants
- K971648: Sharplan Erbium: Yag Laser (4020) (1997), 58 descendants of its own
- K981438: Dornier Medilas E (1998), 56 descendants of its own
- K050317: Burane XL (2005), 53 descendants of its own
- K052806: Burane (2005), 52 descendants of its own
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own

## Indications for use
The MCL 29 Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and in oral and maxillofacial surgery, and ophthalmology (oculoplasty).

Source page: https://510kreport.com/device/K964128
Methodology: https://510kreport.com/methodology