FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES


Device Classification Name

powered laser surgical instrument

510(k) Number K080915
Device Name FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES
Applicant
RELIANT TECHNOLOGIES, INC.
464 ellis st.
mountain view, 
CA 
94043

Applicant Contact heather macfalls
Correspondent
RELIANT TECHNOLOGIES, INC.
464 ellis st.
mountain view, 
CA 
94043

Correspodent Contact heather macfalls
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 04/02/2008
Decision Date 07/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No