SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER


Device Classification Name

powered laser surgical instrument

510(k) Number K103753
Device Name SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
Applicant
SIRONA DENTAL SYSTEMS GMBH
fabrikstrasse 31
bensheim, 

DE

d-64625

Applicant Contact fritz kolle
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 12/23/2010
Decision Date 02/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No