UniVit HE, UniVit UHS— 510(k) K212763

Name: FDA 510(k) clearance K212763
Creator: U.S. Food and Drug Administration
Published: 2022-08-10

Substantially Equivalent

Visioncare Devices, LLC

FDA 510(k) clearance K212763 for UniVit HE, UniVit UHS, Substantially Equivalent on 2022-08-10. Applicant: Visioncare Devices, LLC. Device class: 2.

Clearance details

Applicant: Visioncare Devices, LLC
Product code: Code HQE
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 2021-08-31
Decision date: 2022-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anderson, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQE

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K153168 — Bi-Blade Vitrectomy Cutter2016-04-29
K141065 — CONSTELLATION VISION SYSTEM2014-08-22
K121675 — VERSAVIT2012-06-21
K120170 — PROCARE PLUS VITRECTOMY SYSTEM2012-05-30

Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.