PASCAL STREAMLINE 577 (WITH ACCESSORIES)


Device Classification Name

laser, ophthalmic

510(k) Number K111108
Device Name PASCAL STREAMLINE 577 (WITH ACCESSORIES)
Applicant
TOPCON MEDICAL LASER SYSTEMS, INC
3130 coronado drive
santa clara, 
CA 
95054

Applicant Contact john jossy
Correspondent
TOPCON MEDICAL LASER SYSTEMS, INC
3130 coronado drive
santa clara, 
CA 
95054

Correspodent Contact john jossy
Regulation Number 886.4390
Classification Product Code
HQF  
Date Received 04/20/2011
Decision Date 08/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No