# K082445: CURATIVE980 Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Oroscience, Inc.
- Decided: Oct 15, 2008 after 51 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: 15 generations back to K943450 (1995). 195 ancestors in all.
No later device cites it as a predicate yet.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072034: Diode Medical Laser Family, Models 4, 6, 30, Quanta System Spa (2007) Summary page 1.
- K063384: Diodent Micro Dental Laser System, Models 810 and 980, Hoya Conbio, Inc. (2007) Summary page 1.
- K050824: 100W Ceralas D 980 Laser System, Model D100, Biolitec, Inc. (2005) Summary page 1.
- K993942: Litesaber 2000, Laser Dental Innovations (2000) Summary page 1.
- K052604: Starlite 2006, Laser Dental Innovations (2005) Summary page 1.
- K062363: BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM, B&W Tek, Inc. (2007) Summary page 1.

## Indications for use
The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended to deliver laser energy for incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery as follows: Dental Surgery Indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue (intraoral and extraoral) including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications: * Biopsy * Excisional and incisional biopsies * Excision of lesions * Exposure of unerupted/partially erupted teeth * Fibroma removal * Frenectomy * Frenotomy * Gingival troughing for crown impressions * Gingival troughing * Gingivectomy * Gingivoplasty * Gingival incision and excision * Hemostasis and coagulation * Hemostasis of donor site * Implant recovery * Removal of granulation tissue * Laser assisted flap surgery Dental Surgery - Continued * Debridement of diseased epithelial lining * Treatment of aphthous ulcers * Sulcular debridement (removal of 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) * Laser soft tissue curettage * Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa * Operculectomy * Incision and drainage of abscess * Oral papillectomies; papillectomy * Removal of hyperplastic tissues * Pulpotomy * Pulpotomy as an adjunct to root canal therapy * Reduction of gingival hypertrophy * Reduction of bacterial level (decontamination) and inflammation * Soft tissue crown lengthening; crown lengthening * Tissue retraction for impressions * Leukoplakia * Vestibuloplasty * Light activation of bleaching materials for teeth whitening. * Laser-assisted bleaching/whitening for teeth

Source page: https://510kreport.com/device/K082445
Methodology: https://510kreport.com/methodology