# K192617: Gemini 810+980 Soft Tissue Laser

- Pathway: 510(k) (Traditional)
- Applicant: Azena Medical, LLC
- Decided: Feb 20, 2020 after 150 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: 8 generations back to K922901 (1992). 26 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152032: ELUMI 810 + 980 Soft Tissue Laser, Azena Medical, LLC (2015) Summary page 6.

## Most influential descendants
- K210350: Gemini 2 810+980 Soft Tissue Laser (2021), 1 descendant of its own
- K260765: Gemini NOVA 810+980 Soft Tissue Laser (2026), 0 descendants of its own

## Indications for use
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: • Excisional and incisional biopsies • Exposure of unerupted teeth • Fibroma removal • Frenectomy • Frenotomy • Gingival troughing for crown impressions • Gingivectomy • Gingivoplasty • Gingival incision and excision • Hemostasis and coagulation • Implant recovery • Incision and drainage of abscess • Leukoplakia • Operculectomy • Oral papillectomies • Pulpotomy • Pulpotomy as an adjunct to root canal therapy • Reduction of gingival hypertrophy • Soft tissue crown lengthening • Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa • Treatment of aphthous ulcers. • Vestibuloplasty • Tissue retraction for impression • Lesion (tumor) removal. Laser Periodontal Procedures. • Laser soft tissue curettage. • Laser removal of diseased, Infected, Inflamed 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. • 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) • Reduction of bacterial level (decontamination) and inflammation Pain therapy • 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/K192617
Methodology: https://510kreport.com/methodology