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FDA 510(k)

TROKEL /3 GONIO LASER LENS

K-Number: K921414 · 1992-11-16

ApplicantOcular Instruments, Inc.
Decision Date1992-11-16
Product CodeLQJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TROKEL /3 GONIO 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 1992-11-16 under 510(k) number K921414. The device is classified under product code LQJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROKEL /3 GONIO LASER LENS?

TROKEL /3 GONIO LASER LENS is a medical device that received FDA 510(k) clearance on 1992-11-16. The listed applicant is Ocular Instruments, Inc.. The 510(k) number is K921414.

When did TROKEL /3 GONIO LASER LENS receive FDA 510(k) clearance?

TROKEL /3 GONIO LASER LENS received FDA 510(k) clearance on 1992-11-16, under 510(k) number K921414.

Who is the listed applicant for TROKEL /3 GONIO 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 TROKEL /3 GONIO LASER LENS?

The FDA product code for TROKEL /3 GONIO LASER LENS is LQJ.

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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: LQJ)

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.

K163632Katalyst Cyclophotocoagulation ProbeKatalyst Surgical, LLCK931356SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTORSorenson Laboratories, Inc.K912112PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480Tomey Corporation USAK893731SHIELDS T.C. LASER LENSOcular Instruments, Inc.K884694MQL 20 ND:YAG OPHTHALMIC LASERCalifornia Laboratories, Inc.K883719INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEMBiophysic Medical, 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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