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FDA 510(k)

TBD KERATOSCOPE

K-Number: K912130 · 1991-08-09

ApplicantAlcon Laboratories
Decision Date1991-08-09
Product CodeHLQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TBD KERATOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories. It received FDA 510(k) clearance on 1991-08-09 under 510(k) number K912130. The device is classified under product code HLQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBD KERATOSCOPE?

TBD KERATOSCOPE is a medical device that received FDA 510(k) clearance on 1991-08-09. The listed applicant is Alcon Laboratories. The 510(k) number is K912130.

When did TBD KERATOSCOPE receive FDA 510(k) clearance?

TBD KERATOSCOPE received FDA 510(k) clearance on 1991-08-09, under 510(k) number K912130.

Who is the listed applicant for TBD KERATOSCOPE?

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

What is the FDA product code for TBD KERATOSCOPE?

The FDA product code for TBD KERATOSCOPE is HLQ.

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Other records listing Alcon Laboratories 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.

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Related Devices (Code: HLQ)

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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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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