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)

ENHANCED ULTRA VIT PROBE

K-Number: K093305 · 2010-04-02

ApplicantAlcon Research, Ltd.
Decision Date2010-04-02
Product CodeMLZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ENHANCED ULTRA VIT PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Research, Ltd.. It received FDA 510(k) clearance on 2010-04-02 under 510(k) number K093305. The device is classified under product code MLZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENHANCED ULTRA VIT PROBE?

ENHANCED ULTRA VIT PROBE is a medical device that received FDA 510(k) clearance on 2010-04-02. The listed applicant is Alcon Research, Ltd.. The 510(k) number is K093305.

When did ENHANCED ULTRA VIT PROBE receive FDA 510(k) clearance?

ENHANCED ULTRA VIT PROBE received FDA 510(k) clearance on 2010-04-02, under 510(k) number K093305.

Who is the listed applicant for ENHANCED ULTRA VIT PROBE?

The FDA 510(k) record lists Alcon Research, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENHANCED ULTRA VIT PROBE?

The FDA product code for ENHANCED ULTRA VIT PROBE is MLZ.

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 Alcon Research, Ltd. 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.

K161794CENTURION Vision System (Active SentryTM)K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+K121031WAVELIGHT FS200 PATIENT INTERFACE 1505K112977MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)K11095127+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULAK110166CLEARCUT S SAFETY KNIFE

View all 15 devices →

Related Devices (Code: MLZ)

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.

K220030Vista Ophthalmics Vitrectomy ProbeVista Ophthalmics, LLCK170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+Alcon Research, Ltd.K081681VITRECTOMY CUTTER AND ACCESSORIESAdvanced Medical Optics, Inc.

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.

↑