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FDA 510(k)

MAINSTER HIGH MAGNIFICATION LASER LENS

K-Number: K912366 · 1991-06-25

ApplicantOcular Instruments, Inc.
Decision Date1991-06-25
Product CodeHJK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAINSTER HIGH MAGNIFICATION LASER 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 1991-06-25 under 510(k) number K912366. The device is classified under product code HJK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAINSTER HIGH MAGNIFICATION LASER LENS?

MAINSTER HIGH MAGNIFICATION LASER LENS is a medical device that received FDA 510(k) clearance on 1991-06-25. The listed applicant is Ocular Instruments, Inc.. The 510(k) number is K912366.

When did MAINSTER HIGH MAGNIFICATION LASER LENS receive FDA 510(k) clearance?

MAINSTER HIGH MAGNIFICATION LASER LENS received FDA 510(k) clearance on 1991-06-25, under 510(k) number K912366.

Who is the listed applicant for MAINSTER HIGH MAGNIFICATION LASER 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 MAINSTER HIGH MAGNIFICATION LASER LENS?

The FDA product code for MAINSTER HIGH MAGNIFICATION LASER LENS is HJK.

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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: HJK)

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.

K201909RxSight Contact LensRxsight, Inc.K173944Endocular Viewing Lenses and Silicone RingPhakosK051630SUPER VIEW DISPOSABLE BIOM LENS SETInsight Instruments, Inc.K051103HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORYHaag-Streit USA, Inc.K050623VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV DVolk Optical, Inc.K033950DORC VITRECTOMY LENSES, MODEL 1284 SERIESDutch Ophthalmic Research Center (D.O.R.C.)

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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