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FDA 510(k)

DC-3300 LASER DIODE PHOTOCOAGULATOR

K-Number: K013760 · 2002-02-11

ApplicantNidek, Inc.
Decision Date2002-02-11
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DC-3300 LASER DIODE PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 2002-02-11 under 510(k) number K013760. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DC-3300 LASER DIODE PHOTOCOAGULATOR?

DC-3300 LASER DIODE PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 2002-02-11. The listed applicant is Nidek, Inc.. The 510(k) number is K013760.

When did DC-3300 LASER DIODE PHOTOCOAGULATOR receive FDA 510(k) clearance?

DC-3300 LASER DIODE PHOTOCOAGULATOR received FDA 510(k) clearance on 2002-02-11, under 510(k) number K013760.

Who is the listed applicant for DC-3300 LASER DIODE PHOTOCOAGULATOR?

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 DC-3300 LASER DIODE PHOTOCOAGULATOR?

The FDA product code for DC-3300 LASER DIODE PHOTOCOAGULATOR is HQF.

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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: HQF)

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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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