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FDA 510(k)

SOLARETTES

K-Number: K884878 · 1989-02-22

ApplicantDioptics
Decision Date1989-02-22
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOLARETTES is the device name listed in this FDA 510(k) record. The listed applicant is Dioptics. It received FDA 510(k) clearance on 1989-02-22 under 510(k) number K884878. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLARETTES?

SOLARETTES is a medical device that received FDA 510(k) clearance on 1989-02-22. The listed applicant is Dioptics. The 510(k) number is K884878.

When did SOLARETTES receive FDA 510(k) clearance?

SOLARETTES received FDA 510(k) clearance on 1989-02-22, under 510(k) number K884878.

Who is the listed applicant for SOLARETTES?

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

What is the FDA product code for SOLARETTES?

The FDA product code for SOLARETTES is HQY.

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 Dioptics 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.

K903487SOLARSHIELDS ENCOREK884877OCUSHIELDS MASKSK885163DIOPTICS EYESHIELDSK884929OCCUSHIELDSK862719SOLARSHIELDS

Related Devices (Code: HQY)

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.

K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.K974511SUNGLASSESSun World Intl., Inc.K974441SUNGLASSESHip Shing Fat Co., Ltd.K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.

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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