VELA XL


Device Classification Name

powered laser surgical instrument

510(k) Number K103654
Device Name VELA 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 12/15/2010
Decision Date 04/06/2011
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