# K061366: Denlaser 800 Plus

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Jul 10, 2006 after 55 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) Odyssey 2.4G Diode Laser: named in the summary without a submission number
- (no number) DenLaser 800: named in the summary without a submission number
- (no number) Cynosure Accolade Laser: named in the summary without a submission number

## Indications for use
Dental, oral, and soft tissue surgery including: Sulcular debridement of diseased or fiberous tissue Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown lengthening Operculectomy Frenectomy Photocoagulation

Source page: https://510kreport.com/device/K061366
Methodology: https://510kreport.com/methodology