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FDA 510(k)

NIDEK AC-2000 LASER SYSTEM

K-Number: K860011 · 1986-02-07

ApplicantNidek, Inc.
Decision Date1986-02-07
Product CodeHQB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK AC-2000 LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1986-02-07 under 510(k) number K860011. The device is classified under product code HQB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK AC-2000 LASER SYSTEM?

NIDEK AC-2000 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1986-02-07. The listed applicant is Nidek, Inc.. The 510(k) number is K860011.

When did NIDEK AC-2000 LASER SYSTEM receive FDA 510(k) clearance?

NIDEK AC-2000 LASER SYSTEM received FDA 510(k) clearance on 1986-02-07, under 510(k) number K860011.

Who is the listed applicant for NIDEK AC-2000 LASER SYSTEM?

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

What is the FDA product code for NIDEK AC-2000 LASER SYSTEM?

The FDA product code for NIDEK AC-2000 LASER SYSTEM is HQB.

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Other records listing Nidek, 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.

K050336OPD-STATION SOFTWAREK042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300K031733NON-CONTACT TONOMETER, MODEL NT-4000K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000K013694NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)K020876ECHOSCAN, MODEL US-1800

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Related Devices (Code: HQB)

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.

K220263Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical ChandeliersVortex Surgical, Inc.K191846MAXReach Laser ProbeVortex Surgical, Inc.K182646Vitreq disposable laser probes, light fibers and ChandelierVitreQ BVK132614PEREGRINE CURVED ILLUMINATING LASER PROBEPeregrine Surgical , Ltd.K12299723GA CURVED ILLUMINATING LASER PROBEPeregrine Surgical , Ltd.K122905PEREGRINE 23GA CURVED LASER PROBEPeregrine Surgical , Ltd.

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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