510(k) Report

FDA applicant

Envision, Inc.

Mchenry, IL2 decisions1983–19830 recalls

FDA records 2 decisions for Envision, Inc. (Mchenry, IL) in 1983: 2 510(k) clearances. All are in product code HQC (Unit, Phacofragmentation). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Envision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Envision, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Envision, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HQCUnit, Phacofragmentation2decisions

What has FDA decided for it lately?

  • K832424Envision G31 P.E. PakEnvision, Inc. · 1983
  • K832423Envision G21 I/a EnpakEnvision, Inc. · 1983

All 2 as Envision, Inc. →

Other applicant names beginning “Envision”

FDA records each applicant name separately; these may or may not be the same firm.

Envision Medical Corp. 5Envision Surgical System, Inc. 3Envision Endoscopy 2Envision Advanced Medical System, Ltd. 1