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FDA 510(k)

Hello,eyes® BIO Plug

K-Number: K241229 · 2024-06-28

ApplicantBio Optics Co., Ltd.
Decision Date2024-06-28
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

Hello,eyes® BIO Plug is a medical device manufactured by Bio Optics Co., Ltd.. It received FDA 510(k) clearance on 2024-06-28 under approval number K241229. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hello,eyes® BIO Plug?

Hello,eyes® BIO Plug is a medical device that received FDA 510(k) clearance on 2024-06-28. It is manufactured by Bio Optics Co., Ltd.. The 510(k) number is K241229.

When was Hello,eyes® BIO Plug approved by the FDA?

Hello,eyes® BIO Plug received FDA 510(k) clearance on 2024-06-28, under approval number K241229.

What company makes Hello,eyes® BIO Plug?

Hello,eyes® BIO Plug is manufactured by Bio Optics Co., Ltd..

What is the FDA product code for Hello,eyes® BIO Plug?

The FDA product code for Hello,eyes® BIO Plug is LZU.

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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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