# K072262: Gentleray 980 Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Kavo America
- Decided: Oct 26, 2007 after 72 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: 4 generations back to K922901 (1992). 14 ancestors in all.
51 later devices descend from it; 6 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983058: Ceralas D Laser System, Model # Ceralas D15, Ceram Optec, Inc. (1998) Summary page 2.
- K991891: Ceralas Diode Laser System, Model Ceralas D15, Ceram Optec, Inc. (1999) Summary page 2.
- K023547: Diolase 980 D Laser System, American Dental Technologies, Inc. (2003) Summary page 2.
- K063152: Claros Dental Laser System, Elexxion AG (2007) Summary page 2.

## Most influential descendants
- K092660: Sirolaser Advance (2009), 27 descendants of its own
- K103753: Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser (2011), 26 descendants of its own
- K094049: Stlase Diode Laser (2010), 23 descendants of its own
- K111689: Stlase (2012), 22 descendants of its own
- K170500: SIROLaser Advance+ (2017), 21 descendants of its own

## Indications for use
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.

Source page: https://510kreport.com/device/K072262
Methodology: https://510kreport.com/methodology