Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025606176

FEI Number

3025606176

Entity Name

TENTECH INC.

City/State/Country

Seoul, KR

Establishment Address

#802 Ace Techno Tower 5th, 20, Digital-ro 31-gil, Guro-gu, Seoul 08380, KR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

TENTECH Inc. (Owner Number: 10086925)

Owner / Operator Contact Address

326, Bongeunsa-ro, Gangnam-gu, 4F, 5F, Seoul, KR-11 06143, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220794

PMA Number

N/A

All Registered Proprietary Names

10PL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2022-12-22

Official Correspondent

DONG OK HAN

US Agent Details

Do Hyun Kim Business: BT Solutions USA, LLC Email: ceo@btsolutions.co.kr Phone: (410) 2949140

Related Public Records

Same Entity

TENTECH Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K192521	Shangdong Huamei Technology Co., Ltd.	Intense Pulsed Light Treatment System	2019-12-06

Similar Registrations

Registration Number	Establishment Name	Location
3033891767	Guangzhou Enzoeys photoelectric Technology Co., Ltd.	Guangzhou Guangdong, CN
3006580954	SHENZHEN GSD TECH CO., LTD	Shenzhen Guangdong, CN
3007085226	Vydence Medical Industria e Comercio Ltda	CEAT - Sao Carlos/SP Sao Paulo, BR
3043047259	BLINK BRIGHT MEDICAL, INC.	Houston, TX, US
3012799115	BEIJING GLOBALIPL DEVELOPMENT CO., LTD.	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025606176. Last updated year: 2026. Please use registration number 3025606176 when referencing this establishment in official correspondence.