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FDA 510(k)

BIOINSULATED SILICONE PUNCTUM PLUG

K-Number: K001234 · 2000-07-11

ApplicantAdvanced Vision Science
Decision Date2000-07-11
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

BIOINSULATED SILICONE PUNCTUM PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Vision Science. It received FDA 510(k) clearance on 2000-07-11 under 510(k) number K001234. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOINSULATED SILICONE PUNCTUM PLUG?

BIOINSULATED SILICONE PUNCTUM PLUG is a medical device that received FDA 510(k) clearance on 2000-07-11. The listed applicant is Advanced Vision Science. The 510(k) number is K001234.

When did BIOINSULATED SILICONE PUNCTUM PLUG receive FDA 510(k) clearance?

BIOINSULATED SILICONE PUNCTUM PLUG received FDA 510(k) clearance on 2000-07-11, under 510(k) number K001234.

Who is the listed applicant for BIOINSULATED SILICONE PUNCTUM PLUG?

The FDA 510(k) record lists Advanced Vision Science as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOINSULATED SILICONE PUNCTUM PLUG?

The FDA product code for BIOINSULATED SILICONE PUNCTUM PLUG is LZU.

Related Clinical Trials

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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Other records listing Advanced Vision Science 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.

K980844SURGIDEV SILICONE PUNCTUM 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.K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis 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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