CLEAR+BRILLIANT LASER SYSTEM


Device Classification Name

powered laser surgical instrument with microbeamfractional 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

Correspodent Contact kristine foss
Regulation Number 878.4810
Classification Product Code
ONG  
Date Received 02/07/2011
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