MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE


Device Classification Name

powered laser surgical instrument

510(k) Number K080530
Device Name MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
Applicant
CUTERA, INC.
3240 bayshore blvd
brisbane, 
CA 
94005

Applicant Contact kathy maynor
Correspondent
CUTERA, INC.
3240 bayshore blvd
brisbane, 
CA 
94005

Correspodent Contact kathy maynor
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/26/2008
Decision Date 08/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No