510(k) Report

FDA applicant

Lyma Life, Ltd.

London, GB2 decisions2022–20250 recalls

FDA records 2 decisions for Lyma Life, Ltd. (London, GB) from 2022 to 2025: 2 510(k) clearances. All are in product code OHS (Light Based Over The Counter Wrinkle Reduction). Its devices cite 4 predicates, 1 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 Lyma Life, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12025: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

Planning a device like Lyma Life, 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?

  • OHSLight Based Over The Counter Wrinkle Reduction2decisions

Whose devices does it build on?

Its devices cite 4 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.

  • K210823LYMA LaserLyma Life, Ltd. · 20222cite it

What has FDA decided for it lately?

  • K243330LYMA Laser PROLyma Life, Ltd. · 2025
  • K210823LYMA LaserLyma Life, Ltd. · 2022

All 2 as Lyma Life, Ltd. →