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FDA 510(k)

Soft Plug Extended Duration 180 Canalicular Plug

K-Number: K162361 · 2017-04-17

ApplicantOasis Medical, Inc.
Decision Date2017-04-17
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

Soft Plug Extended Duration 180 Canalicular Plug is a medical device manufactured by Oasis Medical, Inc.. It received FDA 510(k) clearance on 2017-04-17 under approval number K162361. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soft Plug Extended Duration 180 Canalicular Plug?

Soft Plug Extended Duration 180 Canalicular Plug is a medical device that received FDA 510(k) clearance on 2017-04-17. It is manufactured by Oasis Medical, Inc.. The 510(k) number is K162361.

When was Soft Plug Extended Duration 180 Canalicular Plug approved by the FDA?

Soft Plug Extended Duration 180 Canalicular Plug received FDA 510(k) clearance on 2017-04-17, under approval number K162361.

What company makes Soft Plug Extended Duration 180 Canalicular Plug?

Soft Plug Extended Duration 180 Canalicular Plug is manufactured by Oasis Medical, Inc..

What is the FDA product code for Soft Plug Extended Duration 180 Canalicular Plug?

The FDA product code for Soft Plug Extended Duration 180 Canalicular Plug is LZU.

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Other Devices by Oasis Medical, Inc.

K213988SOFT PLUG Extended Duration 180 Tapered Canalicular Plug

Related Devices (Code: LZU)

K161673LacriPro Punctum PlugLacrimedics, Inc. K190210Tear Pool Dissolvable Punctum PlugsAlphamed, Inc. K222164Visant Medical Canalicular PlugVisant Medical, Inc. K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc. K241229Hello,eyes® BIO PlugBio Optics Co., Ltd.

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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