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)

DISPOSABLE CB-PE MICROKERATOME BLADES

K-Number: K003820 · 2001-03-08

ApplicantOasis Medical, Inc.
Decision Date2001-03-08
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE CB-PE MICROKERATOME BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Oasis Medical, Inc.. It received FDA 510(k) clearance on 2001-03-08 under 510(k) number K003820. 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 DISPOSABLE CB-PE MICROKERATOME BLADES?

DISPOSABLE CB-PE MICROKERATOME BLADES is a medical device that received FDA 510(k) clearance on 2001-03-08. The listed applicant is Oasis Medical, Inc.. The 510(k) number is K003820.

When did DISPOSABLE CB-PE MICROKERATOME BLADES receive FDA 510(k) clearance?

DISPOSABLE CB-PE MICROKERATOME BLADES received FDA 510(k) clearance on 2001-03-08, under 510(k) number K003820.

Who is the listed applicant for DISPOSABLE CB-PE MICROKERATOME BLADES?

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

What is the FDA product code for DISPOSABLE CB-PE MICROKERATOME BLADES?

The FDA product code for DISPOSABLE CB-PE MICROKERATOME BLADES 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 Oasis Medical, 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.

K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugK162361Soft Plug Extended Duration 180 Canalicular PlugK032297DISPOSABLE N-PE MICKROKERATOME BLADESK030401DISPOSABLE M2-PE MICROKERATOME BLADESK022205DISPOSABLE N-PE MICROKERATOME BLADESK013613SOFT PLUG ABSORBABLE PLUG-SA

View all 17 devices →

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.

↑