VARILUX VISIONPRINT SYSTEM (VPS)

Device Classification Name

monitor, eye movement

510(k) Number K033949
Device Name VARILUX VISIONPRINT SYSTEM (VPS)
Applicant
ESSILOR INTL.
1301 k street, nw
washington, 
DC 
20005

Applicant Contact marc j scheineson
Correspondent
ESSILOR INTL.
1301 k street, nw
washington, 
DC 
20005

Correspodent Contact marc j scheineson
Regulation Number 886.1510
Classification Product Code
HLL  
Date Received 12/19/2003
Decision Date 07/02/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No