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VisioFocus Mini, VisioFocus Smart

by TECNIMED s.r.l. EUDAMED510(k)

Active European Union and United States

510(k) K160680

Overview

The VisioFocus Mini and VisioFocus Smart are surgical microscopes designed for high-magnification visualization in ophthalmic procedures. These devices provide precise illumination and adjustable magnification to enhance surgical precision during procedures such as cataract surgery, glaucoma interventions, or retinal surgeries, ensuring optimal visibility of delicate ocular structures.

Supplied sterile and intended for single-use, these microscopes are regulated under FDA 510(k) clearance (K160680) and MDR compliance. They are engineered for use in general hospital settings, with no MRI safety restrictions noted. The VisioFocus Mini and VisioFocus Smart are available in compact configurations, requiring minimal space for setup and storage, and are intended for sterile field applications in controlled surgical environments.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK160680 Date19 Apr 2017ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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Questions

  • Are the VisioFocus Mini and VisioFocus Smart microscopes reusable or designed for single-use, and how does this affect their setup in an operating room?

    The VisioFocus Mini and VisioFocus Smart are sterile, single-use devices, meaning each unit is intended for one surgical procedure only. This design eliminates the need for cleaning, sterilization, or reassembly between cases, reducing setup time and potential contamination risks. Clinicians can simply unpack the microscope, attach it to the surgical table, and begin the procedure without additional preparation steps, making them ideal for busy ophthalmic settings where efficiency is critical.

  • What types of ophthalmic procedures are these microscopes primarily intended to support, and how does their adjustable magnification benefit surgeons?

    The VisioFocus Mini and VisioFocus Smart are engineered for high-magnification visualization during delicate ophthalmic surgeries like cataract extraction, glaucoma interventions, and retinal procedures. Their adjustable magnification allows surgeons to zoom in on critical areas of the eye—such as the lens, trabecular meshwork, or retina—with precision, reducing fatigue and improving accuracy in manipulating tiny structures. The precise illumination further enhances visibility of blood vessels, sutures, or implants, which is especially valuable in procedures requiring fine manipulation.

  • How compact are these microscopes, and what storage or setup considerations should clinicians keep in mind?

    The VisioFocus Mini and VisioFocus Smart are designed in compact configurations, requiring minimal space for setup and storage. Their small footprint makes them suitable for tight operating rooms or procedures where space is limited. Since they are single-use and sterile, they can be stored in their original packaging until needed, and no additional sterilization equipment is required. Clinicians should ensure the setup area is clean and free of obstructions to allow for quick attachment to the surgical table and optimal positioning for the surgeon’s view.

  • Are there any special handling or storage requirements for these microscopes before use, particularly regarding sterility?

    Because the VisioFocus Mini and VisioFocus Smart are sterile, single-use devices, they must remain in their original, unopened packaging until immediately before use to maintain sterility. Storage should be in a clean, dry environment protected from moisture, dust, or extreme temperatures. Once unpacked, the microscope should be used promptly in a sterile field, as it is not intended for reuse or reprocessing. This ensures compliance with surgical best practices and minimizes the risk of contamination during procedures.