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)

CHIROFLEX LENS MICROSERT

K-Number: K903574 · 1990-09-17

ApplicantChiron Ophthalmics
Decision Date1990-09-17
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CHIROFLEX LENS MICROSERT is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Ophthalmics. It received FDA 510(k) clearance on 1990-09-17 under 510(k) number K903574. 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 CHIROFLEX LENS MICROSERT?

CHIROFLEX LENS MICROSERT is a medical device that received FDA 510(k) clearance on 1990-09-17. The listed applicant is Chiron Ophthalmics. The 510(k) number is K903574.

When did CHIROFLEX LENS MICROSERT receive FDA 510(k) clearance?

CHIROFLEX LENS MICROSERT received FDA 510(k) clearance on 1990-09-17, under 510(k) number K903574.

Who is the listed applicant for CHIROFLEX LENS MICROSERT?

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

What is the FDA product code for CHIROFLEX LENS MICROSERT?

The FDA product code for CHIROFLEX LENS MICROSERT 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 Chiron Ophthalmics 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.

K915861MEDILENS-CS CORNEAL SHIELDK914311CHIROFLEX II LENS MICROSERT(TM)K905825COLLAGEN SHIELD, VARIOUS MODELSK903575CHIROFLEX FORCEPSK901880MEDILENS(TM) CORNEAL SHIELDK894162OPTISOL

View all 10 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.

↑