CANDELA GENTLELASE FAMILY OF LASER SYSTEMS


Device Classification Name

powered laser surgical instrument

510(k) Number K024260
Device Name CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
Original Applicant
CANDELA CORP.
530 boston post rd.
wayland, 
MA 
01778

Original Contact william h mcgrail
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 12/23/2002
Decision Date 03/21/2003
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

Recalls CDRH Recalls