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FDA 510(k)

NEOLENS SUNGLASSES

K-Number: K882813 · 1988-07-29

ApplicantNeolens, Inc.
Decision Date1988-07-29
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NEOLENS SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Neolens, Inc.. It received FDA 510(k) clearance on 1988-07-29 under 510(k) number K882813. 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 NEOLENS SUNGLASSES?

NEOLENS SUNGLASSES is a medical device that received FDA 510(k) clearance on 1988-07-29. The listed applicant is Neolens, Inc.. The 510(k) number is K882813.

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

NEOLENS SUNGLASSES received FDA 510(k) clearance on 1988-07-29, under 510(k) number K882813.

Who is the listed applicant for NEOLENS SUNGLASSES?

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

What is the FDA product code for NEOLENS SUNGLASSES?

The FDA product code for NEOLENS SUNGLASSES 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Neolens, Inc. 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.

K882814NEOLENS PRESCRIPTION SPECTACLE LENS

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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