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FDA 510(k)

ML MICROKERATOME BLADE

K-Number: K962661 · 1996-12-09

ApplicantMed-Logics, Inc.
Decision Date1996-12-09
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ML MICROKERATOME BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Med-Logics, Inc.. It received FDA 510(k) clearance on 1996-12-09 under 510(k) number K962661. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ML MICROKERATOME BLADE?

ML MICROKERATOME BLADE is a medical device that received FDA 510(k) clearance on 1996-12-09. The listed applicant is Med-Logics, Inc.. The 510(k) number is K962661.

When did ML MICROKERATOME BLADE receive FDA 510(k) clearance?

ML MICROKERATOME BLADE received FDA 510(k) clearance on 1996-12-09, under 510(k) number K962661.

Who is the listed applicant for ML MICROKERATOME BLADE?

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

What is the FDA product code for ML MICROKERATOME BLADE?

The FDA product code for ML MICROKERATOME BLADE is HNO.

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 Med-Logics, 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.

K033293MED-LOGICS, MODEL ML7090K022982MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLBK022716MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLBK010872ML BLADE, MODEL ML7030K010353MED-LOGICS DISPOSABLE ALK TUBINGK002515MEDLOGICS ML 4000, MODEL 4000

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Related Devices (Code: HNO)

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.

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.K172994EPI K ConsoleMoria SAK072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbHK082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KGK062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken Industries

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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