# K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: May 27, 2005 after 94 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: 2 generations back to K011041 (2001). 5 ancestors in all.
86 later devices descend from it; 9 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030539: Lasersmile, Biolase Technology, Inc. (2003) Summary page 5.
- K003541: Denlaser, Model 800, CAO Group, Inc. (2001) Summary page 5.
- K000990: Opus 10 Dental Diode Laser, Opusdent, Ltd. (2000) Summary page 5.
- K993285: Aurora SL, Premier Laser Systems, Inc. (1999) Summary page 5.

## Most influential descendants
- K062258: Genesis Diode Laser (2007), 71 descendants of its own
- K081214: Styla Microlaser and Stylaortho (2008), 50 descendants of its own
- K062619: Denlaser 800 Plus (2006), 40 descendants of its own
- K093852: Ezlase 3 Laser System (2010), 35 descendants of its own
- K121286: EPIC 10 (2012), 31 descendants of its own

## Indications for use
Dental Soft Tissue Indications: Dental, oral and soft tissue surgery including: Sulcular debridement of diseased or fibrous 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 Laser Periodontal procedures, including: 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.

Source page: https://510kreport.com/device/K050453
Methodology: https://510kreport.com/methodology