Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021743553

FEI Number

3021743553

Entity Name

LTBIO CO., LTD.

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

1501, tech-dong, 124, Sagimakgol-ro, Jungwon-gu, Seongnam-si Gyeonggi 13207, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LTBIO Co., Ltd. (Owner Number: 10084318)

Owner / Operator Contact Address

1501, tech-dong, 124, Sagimakgol-ro, Jungwon-gu, Seongnam-si, KR-41 13207, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221189

PMA Number

N/A

All Registered Proprietary Names

OLIZ (model: LTB-1000A)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2022-09-14

Official Correspondent

JAE-YOUNG KIM

US Agent Details

Jung Ryun Ahn Business: KMC USA, Inc Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

LTBIO Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3016214547	RED DOT LED LIGHTING LIMITED	Shenzhen Guangdong, CN
3014296246	PHOTON THERAPY SYSTEMS (PTY) LTD	Pretoria Gauteng, ZA
3033920804	CHONGQING YUYI TECHNOLOGY., CO., LTD.	Chongqing, CN
3015466811	REV-MED INC.	Yongin-si Gyeonggi, KR
3035879449	DONGGUAN JIAYU ELECTRICAL CO.,LTD	Dongguan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021743553. Last updated year: 2026. Please use registration number 3021743553 when referencing this establishment in official correspondence.