CANDELA MID IR DIODE LASER SYSTEM


codes

Device Classification Name

powered laser surgical instrument

510(k) Number K002421
Device Name CANDELA MID IR DIODE LASER SYSTEM
Original Applicant
CANDELA CORP.
530 boston post rd.
wayland, 
MA 
01778

Original Contact joan clifford
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 08/08/2000
Decision Date 11/03/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No