# K042968: MCL 30 Dermablate ER:Yag Laser System

- Pathway: 510(k) (Special)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Nov 24, 2004 after 27 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) DermaStar Er:YAG Laser System: named in the summary without a submission number

## Most influential descendants
- K083253: Lotus II Pulsed ER: Yag Laser System (2009), 1 descendant of its own
- K182045: Lotus III Multi-Pulsed Er: Yag Laser System (2018), 0 descendants of its own

## Indications for use
Intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dennatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes). The smoke evacuator integrated into the handpiece is intended to remove aerosol, a by-product of laser treatment.

Source page: https://510kreport.com/device/K042968
Methodology: https://510kreport.com/methodology