# K103753: Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Feb 15, 2011 after 54 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: 7 generations back to K922901 (1992). 22 ancestors in all.
26 later devices descend from it; 4 cite 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)
- K092660: Sirolaser Advance, Sirona Dental Systems GmbH (2009) Summary page 3.
- (no number) Biolase iLase: named in the summary without a submission number

## Most influential descendants
- 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
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own

## Indications for use
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue;marginal and interdental gingival 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 epithelia] lining ; incisions and draining of abscesses; tissue retraction for impressions papillectomy ; vestibuloplasty ; excision of lesions ; exposure of unenipted/partially erupted teeth ; removal of hyperplastic tissues ;treatment of aphthous ulcers ; leukoplakia ;Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamned and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotorny as adjunct to root canal therapy; Fibroma removal; Gingival incision and excision; Treatment of canker sores; herpetic ulcers of the oral mucosa; Laser soft tissue curettage; Reduction of gingival hypertrophy;. Intra- and extra-oral surgery including incision excision hemostasis, coagulation and vaporization of soft tissue; marginal and interdental gingival 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 ;incisions and draining of abscesses; tissue retraction for impressions ;papillectomy ; vestibuloplasty ;excision of lesions ; exposure of uneruptedlpartially erupted teeth ;removal of hyperplastic tissues ; treatment of aphthous ulcers; leukoplakia ; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotemy as adjunct to root canal therapy; Fibroma removal; Gingival incision and excision; Treatment of canker sores; herpetic ulcers of the oral mucosa; Laser soft tissue curettage; Reduction of gingival hypertrophy;

Source page: https://510kreport.com/device/K103753
Methodology: https://510kreport.com/methodology