# K992707: MCL 29 Dermablate ER:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap-Meditec North America
- Decided: Oct 19, 1999 after 69 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.
54 later devices descend from it; 2 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sharplan Silktouch CO2 Flash Scanner: named in the summary without a submission number
- (no number) Coherent Ultrapulse CO2 Surgical Lasers: named in the summary without a submission number
- (no number) Ultrapulse S Series CO2 Surgical Lasers: named in the summary without a submission number

## Most influential descendants
- 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
- K094052: Lensx 550 Laser System. Model 550 (2010), 47 descendants of its own
- K092647: Lensx 550 Laser System (2009), 31 descendants of its own

## Indications for use
The laser system DERMABLATE ER:YAG LASER SYSTEM is intended for laser assisted site preparation for hair transplantation. This indication is in addition to previously cleared indications. The laser system DERMABLATE ER:YAG LASER SYSTEM is restricted to sale to or use by licensed professionals in the United States.

Source page: https://510kreport.com/device/K992707
Methodology: https://510kreport.com/methodology