# K180967: Dental Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lazon Medical Laser Co., Ltd.
- Decided: Jul 11, 2018 after 89 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: 18 generations back to K943450 (1995). 229 ancestors in all.
No later device cites it as a predicate yet.
0 of 230 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121286: EPIC 10, Biolase Technology, Inc. (2012) Summary page 7.

## Indications for use
The indications for use of the subject device are given below. 1. Dental soft tissue indications Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: - fiborma removal - frenectomy - frenotomy - gingival troughing for crown impressions - gingivectomy - gingivoplasty - hemostasis and coagulation - implant recovery - incision and drainage of abscess - operculectomy - pulpotomy - soft tissue crown lengthening - treatment of herpetic and aphthous ulcers of the oral mucosa. 2. Laser periodontal procedures - laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket - sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.) 3. Whitening - light activation for bleaching materials for teeth whitening - laser-assisted whitening/bleach of teeth 4. Pain Relief - topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle

Source page: https://510kreport.com/device/K180967
Methodology: https://510kreport.com/methodology