# K053161: Sirolaser

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Jan 18, 2006 after 65 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). 10 ancestors in all.
79 later devices descend from it; 8 cite it directly.
0 of 90 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.

## Most influential descendants
- K062258: Genesis Diode Laser (2007), 71 descendants of its own
- 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

## 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 epilhdml lining of frec gingiva, frenectomy frenotomy, biopsy, operculectomy, Implant recovery, gmglveulomy, 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 tmpressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partiaily erupted teeth, removal of hyperplastic tissues, treatiment of aphthous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct (o root canal therapy.

Source page: https://510kreport.com/device/K053161
Methodology: https://510kreport.com/methodology