MODIFICATION TO INTRALASE 600C LASER KERATOME


definition

Device Classification Name

powered laser surgical instrument

510(k) Number K001211
Device Name MODIFICATION TO 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 04/14/2000
Decision Date 12/04/2000
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

Recalls CDRH Recalls