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FDA 510(k)

KRYPTOX-ROUND SEGMENT BIFOCAL

K-Number: K822430 · 1982-12-27

ApplicantPolycore Optical Pte , Ltd.
Decision Date1982-12-27
Product Code
DecisionSubstantially Equivalent

Device Summary

KRYPTOX-ROUND SEGMENT BIFOCAL 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 1982-12-27 under 510(k) number K822430. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRYPTOX-ROUND SEGMENT BIFOCAL?

KRYPTOX-ROUND SEGMENT BIFOCAL is a medical device that received FDA 510(k) clearance on 1982-12-27. The listed applicant is Polycore Optical Pte , Ltd.. The 510(k) number is K822430.

When did KRYPTOX-ROUND SEGMENT BIFOCAL receive FDA 510(k) clearance?

KRYPTOX-ROUND SEGMENT BIFOCAL received FDA 510(k) clearance on 1982-12-27, under 510(k) number K822430.

Who is the listed applicant for KRYPTOX-ROUND SEGMENT BIFOCAL?

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

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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 LENSK822541VISIOPAL 75K822431SUNGLASS & SAFETY PLANO LENSK822542POLYCOREK790215LENS, POLYCORE

View all 7 devices →

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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