# K971912: Protege ER:Yag Laser System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Xintec Corporation
- Decided: Nov 3, 1997 after 206 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 Protégé and Protégé LP Er: YAG Laser Systems and accessories are indicated for incision/excision, ablation, and coagulation (hemostasis) of soft tissue. Soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, mucous membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include: Dentistry Soft tissue (incision, excision, ablation and coagulation) Dermatology and Plastic Surgery Epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitus ulcers Oral/Maxillofacial (benign oral tumor, oral and glossal lesions and gingivectomy) Ear Nose & Throat (ENT), Head and Neck Surgery GI, GU, GYN and Pulmonary Surgery Orthopedic Surgery Thoracic Surgery Ophthalmology Podiatry General Surgery

Source page: https://510kreport.com/device/K971912
Methodology: https://510kreport.com/methodology