510(k) Report

FDA applicant

Ami, Inc.

Seoul, KR4 decisions1986–20240 recalls

FDA records 4 decisions for Ami, Inc. (Seoul, KR) from 1986 to 2024: 4 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and DRO (Pacemaker, Cardiac, External Transcutaneous…). Since 2016 its 510(k)s took a median of 252 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “A.M.I. Corp.”.

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 Ami, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12018: 12024: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ami, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ami, Inc.’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 Instrument3decisions
  • DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 252 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; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc. · 20241cites it

What has FDA decided for it lately?

  • K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc. · 2024
  • K173359Fractional CO2 Surgical Laser SystemAmi, Inc. · 2018
  • K172908Q-Switched Nd:YAG Laser SystemAmi, Inc. · 2017
  • K854924Ami E-Z-Pace ElectodeA.M.I. Corp. · 1986

All 3 as Ami, Inc. →The one decision as A.M.I. Corp. →