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FDA 510(k)

LENS, POLYCORE

K-Number: K790215 · 1979-02-26

ApplicantPolycore Optical Pte , Ltd.
Decision Date1979-02-26
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENS, POLYCORE is the device name listed in this FDA 510(k) record. The listed applicant is Polycore Optical Pte , Ltd.. It received FDA 510(k) clearance on 1979-02-26 under 510(k) number K790215. The device is classified under product code HQG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LENS, POLYCORE?

LENS, POLYCORE is a medical device that received FDA 510(k) clearance on 1979-02-26. The listed applicant is Polycore Optical Pte , Ltd.. The 510(k) number is K790215.

When did LENS, POLYCORE receive FDA 510(k) clearance?

LENS, POLYCORE received FDA 510(k) clearance on 1979-02-26, under 510(k) number K790215.

Who is the listed applicant for LENS, POLYCORE?

The FDA 510(k) record lists Polycore Optical Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LENS, POLYCORE?

The FDA product code for LENS, POLYCORE is HQG.

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Other records listing Polycore Optical Pte , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K832461POLYCOREK822429SINGLE VISION POWER LENSK822430KRYPTOX-ROUND SEGMENT BIFOCALK822541VISIOPAL 75K822431SUNGLASS & SAFETY PLANO LENSK822542POLYCORE

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Related Devices (Code: HQG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K935919SUNGLASSESJa-Ru, Inc.K9207950R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEXOptical Radiation Corp.K900091MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOROnufryk Low Vision Ent.K884360SEIKO P-6 PROGRESSIVE SPECTACLE LENSESSeiko Corp.K882814NEOLENS PRESCRIPTION SPECTACLE LENSNeolens, Inc.K882308CR-39 PLASTIC LENSES FOR EYEGLASSESAutomated Lens System

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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