# K062258: Genesis Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Mar 21, 2007 after 229 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: 5 generations back to K922901 (1992). 17 ancestors in all.
71 later devices descend from it; 10 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050, Ivoclar Vivadent, Inc. (2005) Summary page 3.
- K053161: Sirolaser, Sirona Dental Systems GmbH (2006) Summary page 3.

## Most influential descendants
- K081214: Styla Microlaser and Stylaortho (2008), 50 descendants of its own
- K093852: Ezlase 3 Laser System (2010), 35 descendants of its own
- K121286: EPIC 10 (2012), 31 descendants of its own
- K092660: Sirolaser Advance (2009), 27 descendants of its own
- K103753: Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser (2011), 26 descendants of its own

## Indications for use
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 inflamed edematous tissue.

Source page: https://510kreport.com/device/K062258
Methodology: https://510kreport.com/methodology