# K990914: Polaris Diode Laser System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Xintec Corporation
- Decided: Jul 30, 1999 after 134 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 Polaris Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include: Dermatology and Plastic Surgery for Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions Photothermolysis Dentistry (soft tissue only), including sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and oral surgery; Ear Nose & Throat; Otorhinolaryngology; Neurosurgery (coagulation only); Ophthalmology/Oculoplastic; Pulmonary/Thoracic Surgery; Gastroenterology; Urology; Gynecology; Orthopedics; Podiatry; and General Surgery.

Source page: https://510kreport.com/device/K990914
Methodology: https://510kreport.com/methodology