Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
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.
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.
Gemini 810 + 980 Diode Laser Elumi Soft Tissue Laser
Summary parsed at:2026-06-01 05:46:58 UTC
