510(k) K033949

Device: VARILUX VISIONPRINT SYSTEM (VPS)
Applicant: ESSILOR INTL.
510(k) number: K033949
Product code: HLL
Decision: Substantially Equivalent (SESE)
Decision date: 2004-07-02
Date received: 2003-12-19
Regulation: 886.1510
Classification name: Monitor, Eye Movement
Medical specialty: Ophthalmic
Review panel: Ophthalmic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: MARC J SCHEINESON
Address: 1301 K St., NW Washington DC US 20005 20005

FDA Registration Numbers#

3005785090
3027593072
3003553186
2031962

Source Documents#

Other 510(k) Records For Product Code HLL #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K222484	Retitrack	C. Light Technologies, Inc.	2023-05-09
K152890	SACCADOMETER PLUS, SACCADOMETER ADVANCED	Ober Consulting Sp. Z.O.O.	2016-08-11
K872111	ORTHOTONE	Orthotone Corp.	1988-11-16

Legacy Summary#

summary

FDA Review#

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