Manufacturer registered with FDA

LAON MEDI Inc.

Gwacheon-si, Gyeonggi-do, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10094409Manufacturer2 clearances in five years
Device types listed
1
Brands and models
1
510(k) clearances
22024–2025
Markets registered in
1United States
Establishments
1South Korea
2024: 12025: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What LAON MEDI Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Orthodontic SoftwarePNN · Class 2Dental design & orthodontic softwareMaker
Laon Ortho
2025

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names LAON MEDI Inc. as the applicant.

Decided510(k)DeviceDevice type
23 Apr 2025K250198Laon OrthoPNN Orthodontic Software
12 Mar 2024K232564Align StudioPNN Orthodontic Software

Registered establishments

EstablishmentLocationWhat it does
LAON MEDI INC.FDA reg. 3042204491Gwacheon-si, Gyeonggi-do, South KoreaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10094409). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.