CANDELA-INOLASE SERENITY PRO PSF SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K072925
Device Name CANDELA-INOLASE SERENITY PRO PSF SYSTEM
Applicant
INOLASE, LTD.
291 hillside ave.
somerset, 
MA 
02726

Applicant Contact george j hattub
Correspondent
INOLASE, LTD.
291 hillside ave.
somerset, 
MA 
02726

Correspodent Contact george j hattub
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 10/15/2007
Decision Date 01/10/2008
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