510(k) Report

FDA applicant

Medicreations, LLC

Las Vegas, NV3 decisions2024–20250 recalls

FDA records 3 decisions for Medicreations, LLC (Las Vegas, NV) from 2024 to 2025: 3 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONF (Powered Light Based Non-Laser Surgical…). Since 2016 its 510(k)s took a median of 467 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 0 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 Medicreations, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024: 22025: 1
2024high 2 (2024) · low 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Medicreations, LLC by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medicreations, LLC’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?

  • GEXPowered Laser Surgical Instrument2decisions
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 467 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K231952MedilightMedicreations, LLC · 2025
  • K231948MediyagMedicreations, LLC · 2024
  • K231950MedidiodeMedicreations, LLC · 2024

All 3 as Medicreations, LLC →