# K092660: Sirolaser Advance

- Pathway: 510(k) (Special)
- Applicant: Sirona Dental Systems GmbH
- Decided: Dec 3, 2009 after 97 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: 6 generations back to K922901 (1992). 21 ancestors in all.
27 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053161: Sirolaser, Sirona Dental Systems GmbH (2006) Summary page 2.
- K072262: Gentleray 980 Diode Laser System, Kavo America (2007) Summary page 2.
- K062258: Genesis Diode Laser, Ivoclar Vivadent, Inc. (2007) Summary page 2.
- 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.

## Most influential descendants
- K103753: Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser (2011), 26 descendants of its own
- K170500: SIROLaser Advance+ (2017), 21 descendants of its own
- K180044: SIROLaser Blue (2018), 12 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K210367: D-Laser Blue, D-Laser 16 (2022), 6 descendants of its own

## Indications for use
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. Indications for use are the following applications: marginal and interdental gingiva and epithelial lining of free gingiva, 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, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphthous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy.

Source page: https://510kreport.com/device/K092660
Methodology: https://510kreport.com/methodology