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)

EPIVISION SL SYSTEM

K-Number: K072102 · 2009-01-16

ApplicantGebauer Medizintechnik GmbH
Decision Date2009-01-16
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EPIVISION SL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gebauer Medizintechnik GmbH. It received FDA 510(k) clearance on 2009-01-16 under 510(k) number K072102. 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 EPIVISION SL SYSTEM?

EPIVISION SL SYSTEM is a medical device that received FDA 510(k) clearance on 2009-01-16. The listed applicant is Gebauer Medizintechnik GmbH. The 510(k) number is K072102.

When did EPIVISION SL SYSTEM receive FDA 510(k) clearance?

EPIVISION SL SYSTEM received FDA 510(k) clearance on 2009-01-16, under 510(k) number K072102.

Who is the listed applicant for EPIVISION SL SYSTEM?

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

What is the FDA product code for EPIVISION SL SYSTEM?

The FDA product code for EPIVISION SL SYSTEM 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 Gebauer Medizintechnik GmbH 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.

K041206EPITOME SYSTEM

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 SAK082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KGK062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken IndustriesK051486NORWOOD ABBEY CENTURION SES EPIKERATOMENorwood Abbey , Ltd.

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.

↑