510(k) Report

FDA applicant

Leaseir Technologies, Slu

Gijón, ES2 decisions2022–20261 recall

FDA records 2 decisions for Leaseir Technologies, Slu (Gijón, ES) from 2022 to 2026: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 4 predicates, 1 of them its own earlier devices. 1 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 Leaseir Technologies, Slu’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2022high 1 (2025) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Leaseir Technologies, Slu by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K214049Leaseir MHR XcellLeaseir Technologies, Slu · 20221cites it

What has FDA decided for it lately?

  • K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and…Leaseir Technologies, Slu · 2026
  • K214049Leaseir MHR XcellLeaseir Technologies, Slu · 20221 recall

All 2 as Leaseir Technologies, Slu →

What has been recalled?

1 recall linked to its devices; the latest:

  • K214049Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b…Dec 15, 2025Class II