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FDA 510(k)

SUNGLASS LENSES

K-Number: K822573 · 1982-10-22

ApplicantZEISS
Decision Date1982-10-22
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASS LENSES is the device name listed in this FDA 510(k) record. The listed applicant is ZEISS. It received FDA 510(k) clearance on 1982-10-22 under 510(k) number K822573. 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 SUNGLASS LENSES?

SUNGLASS LENSES is a medical device that received FDA 510(k) clearance on 1982-10-22. The listed applicant is ZEISS. The 510(k) number is K822573.

When did SUNGLASS LENSES receive FDA 510(k) clearance?

SUNGLASS LENSES received FDA 510(k) clearance on 1982-10-22, under 510(k) number K822573.

Who is the listed applicant for SUNGLASS LENSES?

The FDA 510(k) record lists ZEISS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNGLASS LENSES?

The FDA product code for SUNGLASS LENSES is HQG.

Related Clinical Trials

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.

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Other records listing ZEISS 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.

K821263SELECT BIPOLAR COAGULATION FORCEPS

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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