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FDA 510(k)

SOFT PLUG Extended Duration 180 Tapered Canalicular Plug

K-Number: K213988 · 2022-06-03

ApplicantOasis Medical, Inc.
Decision Date2022-06-03
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

SOFT PLUG Extended Duration 180 Tapered Canalicular Plug is the device name listed in this FDA 510(k) record. The listed applicant is Oasis Medical, Inc.. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K213988. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT PLUG Extended Duration 180 Tapered Canalicular Plug?

SOFT PLUG Extended Duration 180 Tapered Canalicular Plug is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is Oasis Medical, Inc.. The 510(k) number is K213988.

When did SOFT PLUG Extended Duration 180 Tapered Canalicular Plug receive FDA 510(k) clearance?

SOFT PLUG Extended Duration 180 Tapered Canalicular Plug received FDA 510(k) clearance on 2022-06-03, under 510(k) number K213988.

Who is the listed applicant for SOFT PLUG Extended Duration 180 Tapered Canalicular Plug?

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

What is the FDA product code for SOFT PLUG Extended Duration 180 Tapered Canalicular Plug?

The FDA product code for SOFT PLUG Extended Duration 180 Tapered Canalicular Plug is LZU.

Other records listing Oasis Medical, Inc. 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.

K162361Soft Plug Extended Duration 180 Canalicular Plug

Related Devices (Code: LZU)

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.

K241229Hello,eyes® BIO PlugBio Optics Co., Ltd.K222164Visant Medical Canalicular PlugVisant Medical, Inc.K190210Tear Pool Dissolvable Punctum PlugsAlphamed, Inc.K162361Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc.K161673LacriPro Punctum PlugLacrimedics, Inc.

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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