Modified Ophthalmic Opir Onufryk Image Deflector

FDA 510(k) K900091 · Onufryk Low Vision Ent.

Substantially Equivalent

510(k) numberK900091

Submission

Device name
Modified Ophthalmic Opir Onufryk Image Deflector
Applicant
Onufryk Low Vision Ent.
Fairport, NY, US
Received
January 5, 1990
Decision date
April 4, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HQG – Lens, Spectacle, Non-Custom (Prescription)
Device class
Class I (low risk)
Regulation
21 CFR 886.5844
Specialty
Ophthalmic

Other 510(k)s with product code HQG

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K935919SunglassesHQG · Traditional Ja-Ru, Inc.02/16/1994SE
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K884360Seiko P-6 Progressive Spectacle LensesHQG · Traditional Seiko Corp.11/15/1988SE
K882814Neolens Prescription Spectacle LensHQG · Traditional Neolens, Inc.07/29/1988SE
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K881225Ophthalmic Spectacle Lens BlanksHQG · Traditional Beta Optical Co, Inc.04/19/1988SE
K875063Seiko Plax Diacoat II & Seiko Plax S.V.P.HQG · Traditional Epson EL Paso, Inc.02/22/1988SE
K874681Swirl - a Pre-Moistened Cleaning Tissue for EyesHQG · Traditional Klockner Contract Packaging, Inc.02/05/1988SE
K873245Ar Diacoat Single Vision LensesHQG · Traditional Seiko Optical Products of America, Inc.10/05/1987SE
K872506Melanite IHQG · Traditional Aura Lens Products07/27/1987SE

Questions and answers

When was Modified Ophthalmic Opir Onufryk Image Deflector cleared by the FDA?

Modified Ophthalmic Opir Onufryk Image Deflector (K900091) received a 510(k) decision of Substantially Equivalent on April 4, 1990, 89 days after the submission was received.

What is the product code of K900091?

The FDA product code is HQG – Lens, Spectacle, Non-Custom (Prescription), a Class I (low risk) device regulated under 21 CFR 886.5844.