Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS

K-Number: K964774 · 1996-12-20

ApplicantFci Ophthalmics, Inc.
Decision Date1996-12-20
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS is the device name listed in this FDA 510(k) record. The listed applicant is Fci Ophthalmics, Inc.. It received FDA 510(k) clearance on 1996-12-20 under 510(k) number K964774. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS?

PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS is a medical device that received FDA 510(k) clearance on 1996-12-20. The listed applicant is Fci Ophthalmics, Inc.. The 510(k) number is K964774.

When did PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS receive FDA 510(k) clearance?

PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS received FDA 510(k) clearance on 1996-12-20, under 510(k) number K964774.

Who is the listed applicant for PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS?

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

What is the FDA product code for PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS?

The FDA product code for PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Fci Ophthalmics, 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.

K061404MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICEK061398SNUG PLUG PUNCTUM PLUGK041869SELF RETAINING BICANALICULUS INTUBATION SETK023758BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)K023400FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANTK030054DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES

View all 13 devices →

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.

↑