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FDA 510(k)

GOTTEX SUNGLASSES

K-Number: K861021 · 1986-06-17

ApplicantPrivate Eyes Sunglass Corp.
Decision Date1986-06-17
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GOTTEX SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Private Eyes Sunglass Corp.. It received FDA 510(k) clearance on 1986-06-17 under 510(k) number K861021. 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 GOTTEX SUNGLASSES?

GOTTEX SUNGLASSES is a medical device that received FDA 510(k) clearance on 1986-06-17. The listed applicant is Private Eyes Sunglass Corp.. The 510(k) number is K861021.

When did GOTTEX SUNGLASSES receive FDA 510(k) clearance?

GOTTEX SUNGLASSES received FDA 510(k) clearance on 1986-06-17, under 510(k) number K861021.

Who is the listed applicant for GOTTEX SUNGLASSES?

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

What is the FDA product code for GOTTEX SUNGLASSES?

The FDA product code for GOTTEX SUNGLASSES is HQG.

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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

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

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