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FDA 510(k)

ABRAHAM IRIDECTOMY LENS (YAG LASER)

K-Number: K862713 · 1986-08-21

ApplicantOcular Instruments, Inc.
Decision Date1986-08-21
Product CodeHKS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ABRAHAM IRIDECTOMY LENS (YAG LASER) 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 1986-08-21 under 510(k) number K862713. 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 ABRAHAM IRIDECTOMY LENS (YAG LASER)?

ABRAHAM IRIDECTOMY LENS (YAG LASER) is a medical device that received FDA 510(k) clearance on 1986-08-21. The listed applicant is Ocular Instruments, Inc.. The 510(k) number is K862713.

When did ABRAHAM IRIDECTOMY LENS (YAG LASER) receive FDA 510(k) clearance?

ABRAHAM IRIDECTOMY LENS (YAG LASER) received FDA 510(k) clearance on 1986-08-21, under 510(k) number K862713.

Who is the listed applicant for ABRAHAM IRIDECTOMY LENS (YAG LASER)?

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 ABRAHAM IRIDECTOMY LENS (YAG LASER)?

The FDA product code for ABRAHAM IRIDECTOMY LENS (YAG LASER) 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.K895846TWO MIRROR GONIO LENSOcular Instruments, Inc.K890977MCINTYRE SURGICAL GONIOLENSOcular Instruments, Inc.K862692KARICKHOFF DIAGNOSTIC/LASER LENSOcular Instruments, Inc.K862512RITCH TRABECULOPLASTY LASER LENSOcular Instruments, Inc.K862024SUSSMAN FOUR MIRROR HAND HELD GONIOPRISMOcular 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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