510(k) Report

FDA applicant

Viora, Ltd.

Neanya, IL11 decisions2009–20200 recalls

FDA records 11 decisions for Viora, Ltd. (Neanya, IL) from 2009 to 2020: 11 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and PBX (Massager, Vacuum, Radio Frequency Induced Heat). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 19 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

3in 2020

2009: 22014: 32015: 12016: 22020: 3
2009high 3 (2014) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Viora, Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Viora, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument4decisions
  • PBXMassager, Vacuum, Radio Frequency Induced Heat4decisions
  • NUVMassager, Vacuum, Light Induced Heating1decision
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 87 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 134 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 32 predicates; 19 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 28 times; 19 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150035V10 systemViora, Ltd. · 201510cite it
  • K090221Reaction SystemViora, Ltd. · 20097cite it
  • K152611V20 systemViora, Ltd. · 20164cite it
  • K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd. · 20163cite it
  • K142093V20 SystemViora, Ltd. · 20142cite it
  • K133837Viora V-TotalViora, Ltd. · 20142cite it

What has FDA decided for it lately?

  • K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd. · 2020
  • K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd. · 2020
  • K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd. · 2020
  • K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd. · 2016
  • K152611V20 systemViora, Ltd. · 2016
  • K150035V10 systemViora, Ltd. · 2015
  • K142093V20 SystemViora, Ltd. · 2014
  • K141904Viora V-TouchViora, Ltd. · 2014

All 11 as Viora, Ltd. →