Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027651556

FEI Number

3027651556

Entity Name

SHENZHEN ZOWEE SMART MANUFACTURING CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

ROOM 101,201,401,501,601 of No.1 Factory bldg, No. 149, Second Industrial Rd, Tangxiachong Community,, Yanluo St, Shenzhen Guangdong 518100, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shenzhen Zowee Smart Manufacturing Co., Ltd. (Owner Number: 10088482)

Owner / Operator Contact Address

ROOM 101, 201, 401, 501, 601 of No.1 Factory Building, No. 149, Second Industrial Road, Tangxiachong Community, Yanluo Street, Bao'an District, Shenzhen, CN-GD 518100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IPL Hair Remove Device UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN Ice Cooling IPL Hair Removal Device UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK Ice Cooling IPL Hair Removal Device Amazfit Balance,Amazfit Balance A2287 UI20 BS,UI20 MP,UI20 BL,UI20 PN,UI20 BR,UI20WG,UI20S WH,UI20S GR,UI20S BS,UI20S MP Ice Cooling IPL Hair Remove Device UI20 DB,UI20 RE,UI20 GP,UI20 PW,UI20S DB,UI20S RE,UI20S PW,UI20S GP,UI20 WH,UI20 GR UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, Ice Cooling IPL Hair Removal Device UI04 PL UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, Ulike Reglow Light Therapy Device UM10 Zepp Clarity ONE, Zepp Clarity Pixie, Zepp Clarity Omni Ice Cooling IPL Hair Remove Device UI06S PR,UI06S PN,UI06S WH IPL Hair Removal Device UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-05-11
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-12-29
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-12-29
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2023-08-11
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-05-11
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-12-29
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-05-11
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-05-11
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2023-07-31
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-05-11
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-12-29

Official Correspondent

No official correspondent registered.

US Agent Details

Jessie Yao Business: MEDRIGHT TECH INC Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

Shenzhen Zowee Smart Manufacturing Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027651556. Last updated year: 2026. Please use registration number 3027651556 when referencing this establishment in official correspondence.