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FDA 510(k)

GOLDLENS(TM)

K-Number: K913239 · 1992-01-31

ApplicantDoran Instruments, Inc.
Decision Date1992-01-31
Product CodeHLZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GOLDLENS(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Doran Instruments, Inc.. It received FDA 510(k) clearance on 1992-01-31 under 510(k) number K913239. The device is classified under product code HLZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOLDLENS(TM)?

GOLDLENS(TM) is a medical device that received FDA 510(k) clearance on 1992-01-31. The listed applicant is Doran Instruments, Inc.. The 510(k) number is K913239.

When did GOLDLENS(TM) receive FDA 510(k) clearance?

GOLDLENS(TM) received FDA 510(k) clearance on 1992-01-31, under 510(k) number K913239.

Who is the listed applicant for GOLDLENS(TM)?

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

What is the FDA product code for GOLDLENS(TM)?

The FDA product code for GOLDLENS(TM) is HLZ.

Related Clinical Trials

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.

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Other records listing Doran 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.

K863956MACULOSCOPE(TM)

Related Devices (Code: HLZ)

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.

K253586RM Electrode (RMH 25-01)Retmap, Inc.K232273RM Electrode (RMH 23-01)Retmap, Inc.K961805TOMEY DTL ELECTRODETomey Corporation USAK926540SOPHER AND BIERER OVUM FORCEPSThomasville Medical Assoc.K844409DTL ELECTRODESauquoit Industries, Inc.K830557ERG-JET ELECTRODEUniverso S.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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