# K160413: Sterling 5W Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Sep 21, 2016 after 218 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
Longest line of descent: 3 generations back to K011041 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050, Ivoclar Vivadent, Inc. (2005) Summary page 4.

## Indications for use
The Sterling Diode Laser is indicated for: Dental soft tissue indications: Dental, oral and soft tissue surgery including: Sulcular debridement of diseased or fibrous tissue, excision and biopsy, gingivectomy and gingivoplasty, lesion (tumor) removal, fibroma removal, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and recontour), crown lengthening, operculectomy, frenectomy, and photocoagulation. Laser periodontal procedures, including: Laser soft tissue curettage; laser removal of diseased, infected and necrosed soft tissue within the periodontal pocket; removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

Source page: https://510kreport.com/device/K160413
Methodology: https://510kreport.com/methodology