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FDA 510(k)

PROCARE PLUS VITRECTOMY SYSTEM

K-Number: K120170 · 2012-05-30

ApplicantVisioncare Devices, Inc.
Decision Date2012-05-30
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PROCARE PLUS VITRECTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Visioncare Devices, Inc.. It received FDA 510(k) clearance on 2012-05-30 under 510(k) number K120170. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCARE PLUS VITRECTOMY SYSTEM?

PROCARE PLUS VITRECTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-30. The listed applicant is Visioncare Devices, Inc.. The 510(k) number is K120170.

When did PROCARE PLUS VITRECTOMY SYSTEM receive FDA 510(k) clearance?

PROCARE PLUS VITRECTOMY SYSTEM received FDA 510(k) clearance on 2012-05-30, under 510(k) number K120170.

Who is the listed applicant for PROCARE PLUS VITRECTOMY SYSTEM?

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

What is the FDA product code for PROCARE PLUS VITRECTOMY SYSTEM?

The FDA product code for PROCARE PLUS VITRECTOMY SYSTEM is HQE.

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Other records listing Visioncare Devices, 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.

K023939VELOCITY ADVANTAGEK971064BAYERS BIMANUAL I/A HANDPIECESK940746VIT CUTTER MODEL 94K904909I/A VITROPHAGE MODEL YPR 2001

Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, Inc.K033390COLIBRI DISPOSABLE VITRECTOMY CUTTERMicroworld Medical Instruments, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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