# K013216: Diodent Dental Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Continuum Electro-Optics, Inc.
- Decided: Feb 27, 2002 after 154 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Aurora by Premier Laser System: named in the summary without a submission number
- (no number) TwiLight by BioLase Technologies: named in the summary without a submission number
- (no number) Dentek LD-15 Diode Laser System by BioLase Technologies: named in the summary without a submission number
- (no number) DioLase ST by American Medical Technology (formerly ADT): named in the summary without a submission number

## Indications for use
For the incision, excision, ablation, vaporization and bemostasis of oral soft tissue. Examples: Excisional and incisional biopsies Exposure of unerupted teeth, Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papiliectomies Pulpotomy Pulpotomy as an adjunt to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Sucular 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) Treatment of aphthous ulcers Vestibuloplasty Biopsy incision and excision Lesion (tumor) removal

Source page: https://510kreport.com/device/K013216
Methodology: https://510kreport.com/methodology