INTRALASE 600C LASER KERATOME


definition

Device Classification Name

powered laser surgical instrument

510(k) Number K002890
Device Name INTRALASE 600C LASER KERATOME
Original Applicant
INTRALASE CORP.
9701 jeronimo road
irvine, 
CA 
92618

Original Contact charline gauthier
Regulation Number 878.4810
Classification Product Code
GEX  
Subsequent Product Code
HNO  
Date Received 09/15/2000
Decision Date 08/09/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls