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FDA 510(k)

ZIMLITE LENS

K-Number: K861960 · 1986-06-09

ApplicantAsahi Optical Co. C/O Rosati Associates, P.C.
Decision Date1986-06-09
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ZIMLITE LENS is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Optical Co. C/O Rosati Associates, P.C.. It received FDA 510(k) clearance on 1986-06-09 under 510(k) number K861960. 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 ZIMLITE LENS?

ZIMLITE LENS is a medical device that received FDA 510(k) clearance on 1986-06-09. The listed applicant is Asahi Optical Co. C/O Rosati Associates, P.C.. The 510(k) number is K861960.

When did ZIMLITE LENS receive FDA 510(k) clearance?

ZIMLITE LENS received FDA 510(k) clearance on 1986-06-09, under 510(k) number K861960.

Who is the listed applicant for ZIMLITE LENS?

The FDA 510(k) record lists Asahi Optical Co. C/O Rosati Associates, P.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZIMLITE LENS?

The FDA product code for ZIMLITE LENS is HQG.

Related Clinical Trials

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Other records listing Asahi Optical Co. C/O Rosati Associates, P.C. 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.

K885133APACERAM ARTIFICIAL DENTAL IMPLANTK893134APACERAM OSSICULAR PROSTHESISK872089APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G)

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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