Product Code: HJI FDA class 1 21 CFR 886.1395

Lens, Fundus, Hruby, Diagnostic

Ophthalmic

The Hruby Diagnostic Fundus Lens is a non-contact ophthalmic lens used in conjunction with a slit-lamp biomicroscope to allow detailed examination of the posterior segment of the eye, including the vitreous, retina, and optic disc. It is classified as FDA Class 1, the lowest risk level, subject only to general controls with no premarket submission required. The product code is HJI, regulated under 21 CFR 886.1395, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.

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FEI Numbers

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Basic Information

Product Code: HJI
Device Class: FDA class 1
Regulation Number: 886.1395
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 8 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K923670	BYRNE EXPULSIVE LENS	Nov 16, 1992	Substantially Equivalent	Ocular Instruments, Inc.
K902138	STRIPE PROJECTOR	Jul 05, 1990	Substantially Equivalent	Academic Catalyst Corp.
K901839	60 FUNDUS CAMERA CF-60UV	Jul 05, 1990	Substantially Equivalent	Canon USA, Inc.
K897186	LASER IMAGING WORK STATION	Mar 12, 1990	Substantially Equivalent	Innovision Medical, Inc.
K820223	OMS QUARTZ INFUSION CONTACT LENS	Feb 05, 1982	Substantially Equivalent	Optical Micro Systems, Inc.
K802971	LANDERS CONTACT LENS	Feb 05, 1981	Substantially Equivalent	Cooper Medical Devices Corp.
K802927	SEBESTYEN IRRIGATING CONTACT LENS	Feb 05, 1981	Substantially Equivalent	Cooper Medical Devices Corp.
K760949	CHARLES IRRIGATING FUNDUS CONTACT LENS	Nov 11, 1976	Substantially Equivalent	Richard'S Medical Equip., Inc.