# K983215: Multipulse CO2 Laser

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap-Meditec GmbH
- Decided: Dec 4, 1998 after 81 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.
377 later devices descend from it; 1 cites it directly.
0 of 378 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) M.L.T. 30: named in the summary without a submission number

## Most influential descendants
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (2002), 376 descendants of its own
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers (2003), 323 descendants of its own
- K031795: Reliant Laser System (2003), 318 descendants of its own
- K040617: Reliant Laser System II (2004), 316 descendants of its own
- K042319: Reliant Laser II System and Accessories (2005), 284 descendants of its own

## Indications for use
The Aesculap-Meditec CO, laser is intended for the ablation, vaporization, inciston, excision, and or cutting of soff tissue in: Oral surgery Dermatology Examples: Removal of smalt skin tumors, superficial pigmented lesions, adeno-sebaceous hypertrophy, treatment of scars, skin tags, etc. Skin resurfacing (scanning mode) Blepharoplasty EN.T. Examples: Tumor surgery of the larynx and pharynx LAUP Stenosis CAUTION: Patients should be diagnosed with tissue problems to exclude those whose problems are caused by being overweight or to drinking problems. Remind patients that there may be vocalization problems after laser surgery. Gynaecology The examples are not intended to be exhaustive or complete but to serve as a general guide to the surgeon.

Source page: https://510kreport.com/device/K983215
Methodology: https://510kreport.com/methodology