510(k) Report

FDA applicant

Sls Biophile, Ltd.

Llanelli, GB1 decision2000–20000 recalls

FDA records 1 decision for Sls Biophile, Ltd. (Llanelli, GB) in 2000: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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 Sls Biophile, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sls Biophile, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sls Biophile, Ltd. by year, 2007–2026Sources: 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 Instrument1decision

Who builds on its devices?

Later devices cite its devices 7 times; 0 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.

  • K000811Nlite System, SLS Model Number A00-1025Sls Biophile, Ltd. · 20007cite it

What has FDA decided for it lately?

  • K000811Nlite System, SLS Model Number A00-1025Sls Biophile, Ltd. · 2000

The one decision as Sls Biophile, Ltd. →