# K982548: MLT 30 Laser

- Pathway: 510(k) (Traditional)
- Applicant: Medical Laser Technologies, Ltd.
- Decided: Oct 19, 1998 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Medical Laser Technology, Inc. MLT 30 CO₂ Laser: named in the summary without a submission number

## Indications for use
The M L.T. 36 CO, laseris intended for the ablation, vaporization, incisiomn; excision;, and or cutting of soft tissue in: Oral surgery Dermatology Examples: Removat 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 larymx 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{aser 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/K982548
Methodology: https://510kreport.com/methodology