Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039443708

FEI Number

3039443708

Entity Name

SHENZHEN KESITE DIGITAL TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

1508E2, Building A, Xingheshiji, No. 3069, Caitian Road, Gangxia Community, Futian Street, Futian District, Shenzhen Guangdong 518000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Kesite Digital Technology Co., Ltd. (Owner Number: 10093764)

Owner / Operator Contact Address

1508E2, Building A, Xingheshiji, No. 3069, Caitian Road, Gangxia Community, Futian Street, Futian District, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K801921

PMA Number

N/A

All Registered Proprietary Names

HM-CRYO Tag & Wart Removal Kit Douzino Tongue Stabilizing Device Mouthpiece; IFGZQU Tongue Stabilizing Device Mouthpiece L.C.S.3000 Skin Removal Kit Red Light Therapy Device Upverxi Snore Mouthguard; SnoreBandit Anti-Snoring Appliance Breaspec Skin Tag Remover Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2026-01-16
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2025-12-26
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2026-01-16
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-07-04
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2025-07-23
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-09-05

Official Correspondent

Tongbin Xu

US Agent Details

Terry Chai Email: Terry.Chai.Nj@Hotmail.Com Phone: (908) 6361278

Related Public Records

Same Entity

Shenzhen Kesite Digital Technology Co., Ltd.

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
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039443708. Last updated year: 2026. Please use registration number 3039443708 when referencing this establishment in official correspondence.