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)

AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE

K-Number: K941603 · 1994-07-06

ApplicantAllergan Medical Optics
Decision Date1994-07-06
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Allergan Medical Optics. It received FDA 510(k) clearance on 1994-07-06 under 510(k) number K941603. The device is classified under product code KYB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE?

AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE is a medical device that received FDA 510(k) clearance on 1994-07-06. The listed applicant is Allergan Medical Optics. The 510(k) number is K941603.

When did AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE receive FDA 510(k) clearance?

AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE received FDA 510(k) clearance on 1994-07-06, under 510(k) number K941603.

Who is the listed applicant for AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE?

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

What is the FDA product code for AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE?

The FDA product code for AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE is KYB.

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 Allergan Medical Optics 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.

K951462AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEMK930320AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTRK925254AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38K924235AMO ELITEK911998MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEMK893199PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR

View all 7 devices →

Related Devices (Code: KYB)

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.

K081382DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786Duckworth & Kent, Ltd.K072985DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2Duckworth & Kent, Ltd.K070669IOL INJECTOR SETMedicel AGK063155MONARCH III IOL DELIVERY SYSTEMAlcon Manufacturing, Ltd.K063694AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28Bausch & Lomb, Inc.K032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SStaar Surgical Co.

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.

↑