AURIGA XL


Device Classification Name

powered laser surgical instrument

510(k) Number K111475
Device Name AURIGA XL
Applicant
STARMEDTEC GMBH
kreuzstrasse 22
starnberg, 

DE

82319

Applicant Contact gregor weidemann
Correspondent
STARMEDTEC GMBH
kreuzstrasse 22
starnberg, 

DE

82319

Correspodent Contact gregor weidemann
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/27/2011
Decision Date 09/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls