# K981627: Protege II ER: Yag Laser System and Accessoies (Upgrade)

- Pathway: 510(k) (Traditional)
- Applicant: Xintec Corporation
- Decided: Jul 31, 1998 after 85 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 II Er:YAG Laser Systems and accessories are indicated for the surgical incision/excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Dentistry: Soft tissue (incision, excision, ablation and coagulation) Dermatology/Plastic Surgery: Indications include epidermal nevi, telangiectasia, spider veins, actinic keratosis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacing, superficial skin lesions, and performing diagnostic biopsies. General Surgery: Indications include surgical incision/excision, vaporization, ablation and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated. Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminata, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon. Gynecology: Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. Oral/Maxillofacial: Indications include benign oral tumor, oral and glossal lesions and gingivectomy. Otorhinolaryngology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue and oral leukoplakia. Ophthalmology: Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy. Podiatry: Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy. Arthroscopy, including open and laparoscopic procedures Orthopedic Surgery Thoracic Surgery

Source page: https://510kreport.com/device/K981627
Methodology: https://510kreport.com/methodology