FDA 510(k)

OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES

K-Number: K013445 · 2001-12-26

ApplicantFlorida Optical Engineering, Inc.

Decision Date2001-12-26

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Florida Optical Engineering, Inc.. It received FDA 510(k) clearance on 2001-12-26 under 510(k) number K013445. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES?

OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES is a medical device that received FDA 510(k) clearance on 2001-12-26. The listed applicant is Florida Optical Engineering, Inc.. The 510(k) number is K013445.

When did OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES receive FDA 510(k) clearance?

OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES received FDA 510(k) clearance on 2001-12-26, under 510(k) number K013445.

Who is the listed applicant for OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES?

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

What is the FDA product code for OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES?

The FDA product code for OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES is LPL.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: LPL)

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.