IFS LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K073404
Device Name IFS LASER SYSTEM
Applicant
INTRALASE CORP.
5 grindlay pl
aliso viejo, 
CA 
92656

Applicant Contact maureen weiner
Correspondent
INTRALASE CORP.
5 grindlay pl
aliso viejo, 
CA 
92656

Correspodent Contact maureen weiner
Regulation Number 878.4810
Classification Product Code
GEX  
Subsequent Product Code
HNO  
Date Received 12/04/2007
Decision Date 04/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No