Manufacturer
Azena Medical, LLCGemini 810+980 Soft Tissue Laser
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K192617
- Device name
- Gemini 810+980 Soft Tissue Laser
- Company
- Azena Medical, LLC
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-09-23
- Decision date
- 2020-02-20
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
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.
Intended 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, 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.
Device Description
Gemini 810 + 980 Diode Laser Elumi Soft Tissue Laser
Summary parsed at:2026-06-01 05:46:58 UTC
Predicate devices
2—
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Not ingested
ELUMI 810 + 980 Soft Tissue Laser
K192617 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K192617 as a predicate
