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FDA 510(k)

OcuMet Beacon (OCUB100)

K-Number: K241931 · 2025-04-22

Decision Date2025-04-22
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OcuMet Beacon (OCUB100) is the device name listed in this FDA 510(k) record. The listed applicant is Ocusciences, Inc.. It received FDA 510(k) clearance on 2025-04-22 under 510(k) number K241931. The device is classified under product code MYC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OcuMet Beacon (OCUB100)?

OcuMet Beacon (OCUB100) is a medical device that received FDA 510(k) clearance on 2025-04-22. The listed applicant is Ocusciences, Inc.. The 510(k) number is K241931.

When did OcuMet Beacon (OCUB100) receive FDA 510(k) clearance?

OcuMet Beacon (OCUB100) received FDA 510(k) clearance on 2025-04-22, under 510(k) number K241931.

Who is the listed applicant for OcuMet Beacon (OCUB100)?

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

What is the FDA product code for OcuMet Beacon (OCUB100)?

The FDA product code for OcuMet Beacon (OCUB100) is MYC.

Related Devices (Code: MYC)

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.

Official Source

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