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510(k) K772024

Device
RX LENS SERIES
Applicant
GENTEX CORPORATION
510(k) number
K772024
Product code
HQG  
Decision
Substantially Equivalent (SESE)
Decision date
1977-11-09
Date received
1977-10-26
Regulation
886.5844
Classification name
Lens, Spectacle, Non-custom (prescription)
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HQG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K935919SUNGLASSESJa-Ru, Inc.1994-02-16
K9207950R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEXOptical Radiation Corp.1992-07-13
K900091MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOROnufryk Low Vision Ent.1990-04-04
K884360SEIKO P-6 PROGRESSIVE SPECTACLE LENSESSeiko Corp.1988-11-15
K882814NEOLENS PRESCRIPTION SPECTACLE LENSNeolens, Inc.1988-07-29
K882308CR-39 PLASTIC LENSES FOR EYEGLASSESAutomated Lens System1988-07-22
K881225OPHTHALMIC SPECTACLE LENS BLANKSBeta Optical Co, Inc.1988-04-19
K875063SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.Epson EL Paso, Inc.1988-02-22
K874681SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYESKlockner Contract Packaging, Inc.1988-02-05
K873245AR DIACOAT SINGLE VISION LENSESSeiko Optical Products of America, Inc.1987-10-05
K872506MELANITE IAura Lens Products1987-07-27
K871961MULTIPLE SPECTACLE LENSKorea Asahi Optical Co., Ltd.1987-06-03
K865103KROM-X LENS SYSTEMNeo Optics, Inc.1987-01-20
K863367FORMALENS 2000Vision-Sciences, Inc.1986-09-26
K862578TECHNA VISION CASTING RESINTechna Vision1986-07-23

Legacy Summary#

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FDA Review#

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