Manufacturer
Azena Medical, LLCELUMI 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
Device details
FDA 510(k) registration fields
- K number
- K152032
- Device name
- ELUMI 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
- 2015-07-22
- Decision date
- 2015-09-16
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
• Excisional and incisional biopsies • Exposure of unerupted teeth • Fibroma removal • Gingivoplasty • Hemostasis and coagulation • Incision and drainage of abscess • Operculectomy • Pulpotomy • Reduction of gingival hypertrophy • Soft tissue crown lengthening • Vestibuloplasty • Laser Soft Tissue Curettage • Tissue retraction • Frenectomy and Frenotomy • Gingival troughing for crown impressions • Gingivectomy • Gingival incision and excision • Implant recovery • Leukoplakia • Oral papillectomies • Pulpotomy as an adjunct to root canal therapy • Reduction of bacterial level (decontamination) and inflammation • Treatment of aphthous ulcers • Lesion (tumor) removal • Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa • Removal of Diseased, Infected, Inflamed and necrotic 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 necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) • Light activation for bleaching materials for teeth whitening • Laser-assisted whitening/bleaching of teeth
Intended Use
• Excisional and incisional biopsies • Exposure of unerupted teeth • Fibroma removal • Gingivoplasty • Hemostasis and coagulation • Incision and drainage of abscess • Operculectomy • Pulpotomy • Reduction of gingival hypertrophy • Soft tissue crown lengthening • Vestibuloplasty • Laser Soft Tissue Curettage • Tissue retraction • Frenectomy and Frenotomy • Gingival troughing for crown impressions • Gingivectomy • Gingival incision and excision • Implant recovery • Leukoplakia • Oral papillectomies • Pulpotomy as an adjunct to root canal therapy • Reduction of bacterial level (decontamination) and inflammation • Treatment of aphthous ulcers • Lesion (tumor) removal • Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa • Removal of Diseased, Infected, Inflamed and necrotic 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 necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) • Light activation for bleaching materials for teeth whitening • Laser-assisted whitening/bleaching of teeth
Device Description
ELUMI 810 + 980 Soft Tissue Laser Type of Laser: Diode Laser Laser Medium: GaAlAs Wavelength: 810 ± 10nm; or 980 ± 10nm; or 810nm and 980nm ± 10nm Average Output Power: Adjustable 0.1 - 2 Watts Max Peak Output Power: 10 Watts @ 810nm; 10 Watts @ 980nm; 20 Watts @ 810nm + 980nm Operating Voltage: 100-240 VAC Current Frequency: 50-60 HZ Operation Mode: Pulsed Pulse Type: Gated Battery: Lithium Ion Rechargeable Delivery System: Quartz glass fiber & tip* Fiber/Tip Diameter: 400 µm core Fiber Aiming Beam: 5mW laser diode, 650nm, Class 1 Activation Means: Wireless Foot Switch, with electronic access key *The quartz glass fiber within ELUMI's single-use fiber tip is the only system component that comes in direct or indirect contact with patients.
Summary parsed at:2026-06-01 06:11:30 UTC
Predicate devices
2Cited as predicate
2Gemini 810+980 Soft Tissue Laser
Epic 980
2 submissions cite K152032 as a predicate