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FDA 510(k)

OCULAR FORCE GAUGE

K-Number: K132917 · 2013-12-20

ApplicantOcular Therapeutix, Inc.
Decision Date2013-12-20
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCULAR FORCE GAUGE is the device name listed in this FDA 510(k) record. The listed applicant is Ocular Therapeutix, Inc.. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K132917. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCULAR FORCE GAUGE?

OCULAR FORCE GAUGE is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Ocular Therapeutix, Inc.. The 510(k) number is K132917.

When did OCULAR FORCE GAUGE receive FDA 510(k) clearance?

OCULAR FORCE GAUGE received FDA 510(k) clearance on 2013-12-20, under 510(k) number K132917.

Who is the listed applicant for OCULAR FORCE GAUGE?

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

What is the FDA product code for OCULAR FORCE GAUGE?

The FDA product code for OCULAR FORCE GAUGE is HKY.

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Related Devices (Code: HKY)

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

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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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