CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS


Device Classification Name

powered laser surgical instrument

510(k) Number K081324
Device Name CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS
Applicant
CANDELA CORP.
530 boston post road
wayland, 
MA 
01778

Applicant Contact lisa lacroix
Correspondent
CANDELA CORP.
530 boston post road
wayland, 
MA 
01778

Correspodent Contact lisa lacroix
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/12/2008
Decision Date 06/17/2008
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