# K982860: UM-L20/ UM-L30

- Pathway: 510(k) (Traditional)
- Applicant: Union Medical Engeneering Co., Ltd.
- Decided: Aug 13, 1999 after 365 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The UM-L20/UML30 CO2 Laser Units are used in the following spplications in order to treat the below mentioned conditions: ENT: Adenoidectomy; Orzal Tumors; Rhinophyma; Tumors; Nasal Polyps; Hemostasis; Rhinitis; Keratosis; Tonsillectomy; Verruce; Skin Tags; Skin Incisions; Verruce; Nevi Plastic & Reconstruction: Xanthoma; Nasal Polyps; Condyloma; Rhinitis; Tumors; Telangiectasia; Hemostasis; Rhinophyma; Keloids; Verruce; Skin Tags; Nevi; Skin Tags; Dark Spots; Corn; Syringoma Dermatology: Xanthoma; Telangiectasia; Rhinophyma; Condyloma; Tumors; Hemostasis; Keloids; Verruce; Skin Tags; Nevi; Keratosis Podiatry: Tumors; Hemostasis; Keloids; Verruce; Skin Tags; Nevi; Skin Incisions Dentalogy: Gingival Incision & Excision; Tissue Retraction for Impression; Frenectomy & Frenotomy; Aphthous Ulcers; Excisional & Incisional Biopsies; Draining of Abscesses; Hemostatic Assistance; Implant Exposure; Soft Tissue; Crown Lengthaing; Operculectomy General Practice: Rhinitis; Xanthoma; Condyloma; Tumors; Keloids; Keratosis; Verrucae; Skin Tags; Nevi Gynecology: Condyloma; Conization; Tumors; Hemostasis; Keloids; Keratosis; Verrucae; Skin Tags; Nevi Proctology: Tumors; Hemostasis; Hemorrhoids; Keloids; Keratosis; Verrucae; Skin Tags; Nevi; Skin Incisions

Source page: https://510kreport.com/device/K982860
Methodology: https://510kreport.com/methodology