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FDA 510(k)

TWO MIRROR GONIO LENS

K-Number: K895846 · 1989-12-18

ApplicantOcular Instruments, Inc.
Decision Date1989-12-18
Product CodeHKS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TWO MIRROR GONIO LENS is the device name listed in this FDA 510(k) record. The listed applicant is Ocular Instruments, Inc.. It received FDA 510(k) clearance on 1989-12-18 under 510(k) number K895846. The device is classified under product code HKS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWO MIRROR GONIO LENS?

TWO MIRROR GONIO LENS is a medical device that received FDA 510(k) clearance on 1989-12-18. The listed applicant is Ocular Instruments, Inc.. The 510(k) number is K895846.

When did TWO MIRROR GONIO LENS receive FDA 510(k) clearance?

TWO MIRROR GONIO LENS received FDA 510(k) clearance on 1989-12-18, under 510(k) number K895846.

Who is the listed applicant for TWO MIRROR GONIO LENS?

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

What is the FDA product code for TWO MIRROR GONIO LENS?

The FDA product code for TWO MIRROR GONIO LENS is HKS.

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Other records listing Ocular Instruments, 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.

K014170STAURENGHI WIDE FIELD SCANNING LASER LENSK012096DISPOSABLE VITRECTOMY LENSK933976MANDELKORN SUTURE LYSIS LENSK933264RITCH NYLON SUTURE LASER LENSK94142050 DEGREE HRI PRISM LENSK935302OSHER SURGICAL GONIO/POSTERIOR POLE LENS

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Related Devices (Code: HKS)

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.

K935302OSHER SURGICAL GONIO/POSTERIOR POLE LENSOcular Instruments, Inc.K890977MCINTYRE SURGICAL GONIOLENSOcular Instruments, Inc.K862713ABRAHAM IRIDECTOMY LENS (YAG LASER)Ocular Instruments, Inc.K862692KARICKHOFF DIAGNOSTIC/LASER LENSOcular Instruments, Inc.K862024SUSSMAN FOUR MIRROR HAND HELD GONIOPRISMOcular Instruments, Inc.K862512RITCH TRABECULOPLASTY LASER LENSOcular Instruments, 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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