Device Classification Name powered laser surgical instrument with microbeam\fractional output
510(k) Number K110349
Device Name CLEAR+BRILLIANT LASER SYSTEM
Applicant
SOLTA MEDICAL, INC.
25881 INDUSTRIAL BLVD.
hayward,  CA  94545
Applicant Contact kristine foss
Correspondent
SOLTA MEDICAL, INC.
25881 INDUSTRIAL BLVD.
hayward,  CA  94545
Correspondent Contact kristine foss
Regulation Number878.4810
Classification Product Code
ONG  
Date Received02/07/2011
Decision Date 05/03/2011
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