Data / Medical devices / South Korea / Ami Inc.
Ami Inc.: FDA-registered device maker in Geumcheon-gu Seoul, South Korea, 3 510(k) clearances
Ami Inc. is registered with the FDA (registration 3014253920) in Geumcheon-gu Seoul, South Korea. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated June 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014253920
- Address
- RM.1407, 1408, 1409, SJ Techno Ville, 278, Beotkkot-ro, Geumcheon-gu Seoul, South Korea, 08511
- Owner or operator
- AMI INC. (10056500)
- Roles
- Manufacturer
- First device listed
- December 15, 2017
- Registered through
- 2026
- Brand names listed
- BIOXEL Fractional CO2 Laser System, COLORMAX PICO Picosecond Nd:YAG Laser System, COLORMAX PLUS Q-Switched Nd:YAG Laser System, IBLAZE Fractional CO2 Laser System, PICO LEGEND Picosecond Nd:YAG Laser System, Q-MASTER Q-Switched Nd:YAG Laser System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2024 | K233007 | Picosecond Nd:YAG Laser System; PICO LEGEND | GEX | Substantially Equivalent | Ami, Inc. | accessdata.fda.gov |
| July 5, 2018 | K173359 | Fractional CO2 Surgical Laser System | GEX | Substantially Equivalent | Ami, Inc. | accessdata.fda.gov |
| December 7, 2017 | K172908 | Q-Switched Nd:YAG Laser System | GEX | Substantially Equivalent | Ami, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.