510(k) Report

FDA applicant

Termosalud

Gijon, ES8 decisions2023–20260 recalls

FDA records 8 decisions for Termosalud (Gijon, ES) from 2023 to 2026: 8 510(k) clearances. Most are in product codes PBX (Massager, Vacuum, Radio Frequency Induced Heat) and GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 64 days from receipt to decision, against 118 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Termosalud S.L.”.

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 Termosalud’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2023: 32024: 12025: 22026 (partial year): 2
2023high 3 (2023) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Termosalud by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • PBXMassager, Vacuum, Radio Frequency Induced Heat3decisions
  • GEXPowered Laser Surgical Instrument2decisions
  • NGXStimulator, Muscle, Powered, For Muscle Conditioning1decision
  • ISAMassager, Therapeutic, Electric1decision
  • OHSLight Based Over The Counter Wrinkle Reduction1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 64 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 118 days; 7 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K230412Symmed Elite AestheticTermosalud · 20231cites it
  • K241656Eneka SelectifTermosalud · 20241cites it

What has FDA decided for it lately?

  • K261473ChromixTermosalud S.L. · 2026
  • K253636Zionic Pro Max (EMS)Termosalud S.L. · 2026
  • K243716Zionic Pro Max (Radiofrequency)Termosalud S.L. · 2025
  • K243488Vmat ProTermosalud · 2025
  • K241656Eneka SelectifTermosalud · 2024
  • K230659Zionic AestheticTermosalud · 2023
  • K230412Symmed Elite AestheticTermosalud · 2023
  • K223680Eneka ProTermosalud · 2023

All 5 as Termosalud →All 3 as Termosalud S.L. →