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FDA 510(k)

NEOLENS PRESCRIPTION SPECTACLE LENS

K-Number: K882814 · 1988-07-29

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

Device Summary

NEOLENS PRESCRIPTION SPECTACLE LENS 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 K882814. 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 NEOLENS PRESCRIPTION SPECTACLE LENS?

NEOLENS PRESCRIPTION SPECTACLE LENS 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 K882814.

When did NEOLENS PRESCRIPTION SPECTACLE LENS receive FDA 510(k) clearance?

NEOLENS PRESCRIPTION SPECTACLE LENS received FDA 510(k) clearance on 1988-07-29, under 510(k) number K882814.

Who is the listed applicant for NEOLENS PRESCRIPTION SPECTACLE LENS?

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 PRESCRIPTION SPECTACLE LENS?

The FDA product code for NEOLENS PRESCRIPTION SPECTACLE LENS 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.

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.

K882813NEOLENS SUNGLASSES

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.K882308CR-39 PLASTIC LENSES FOR EYEGLASSESAutomated Lens SystemK881225OPHTHALMIC SPECTACLE LENS BLANKSBeta Optical Co, Inc.

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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