510(k) Report

FDA applicant

Ipg Medical Corporation

Marlborough, MA3 decisions2024–20251 recall

FDA records 3 decisions for Ipg Medical Corporation (Marlborough, MA) from 2024 to 2025: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 210 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Ipg Medical”.

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 Ipg Medical Corporation’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

1in 2026

2026 (partial year): 1
2024high 1 (2026) · low 0 (2024)2026

Class I Class II/III not classified

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

Planning a device like Ipg Medical Corporation’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?

  • GEXPowered Laser Surgical Instrument3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 210 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 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.

  • K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation · 20241cites it

What has FDA decided for it lately?

  • K251100Ipgtfl-02Ipg Medical Corporation · 2025
  • K233344Regenalase Laser SystemIpg Medical · 2024
  • K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation · 20241 recall

All 2 as Ipg Medical Corporation →The one decision as Ipg Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K232568Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.May 5, 2026Class II