# Ami, Inc.

- Location (FDA's records): Seoul, KR
- FDA decisions: 4 (1986–2024): 4 510(k) clearances
- Names in FDA's records: Ami, Inc. (3); A.M.I. Corp. (1)
- Product codes: GEX (3), DRO (1)
- 510(k) review time since 2016: median 252 days, against 90 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Med USA, Inc.: 1 (https://510kreport.com/company/bio-med-usa)
- Ids, Ltd.: 1 (https://510kreport.com/company/ids)
- Wontech Co., Ltd.: 1 (https://510kreport.com/company/wontech)

## Firms that cite its devices most
- Risu Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/risu-medical-technology)

## Its most-cited devices
- K233007: Picosecond Nd:YAG Laser System; PICO LEGEND (2024), cited by 1

## Recent decisions
- K233007: Picosecond Nd:YAG Laser System; PICO LEGEND (Jun 12, 2024)
- K173359: Fractional CO2 Surgical Laser System (Jul 5, 2018)
- K172908: Q-Switched Nd:YAG Laser System (Dec 7, 2017)
- K854924: Ami E-Z-Pace Electode (Feb 26, 1986)

Source page: https://510kreport.com/company/ami