Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010027944

FEI Number

3010027944

Entity Name

TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

7/F, Marina Bay Centre A, South of Xinhua Road, Bao'an Centre Area, Xin'an Street Bao'an District, Shenzhen Guangdong 518100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD. (Owner Number: 10056661)

Owner / Operator Contact Address

29/F, Block B, Tiley Central Business Plaza, Haide 3rd Road, Nanshan District, Shenzhen, CN-GD 518064, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Facial Cleanser,Electric Facial Cleanser Set ultrasonic scrubber LED LIGHT THERAPY DEVICE Sharper Image: 1019057 Light Therapy Pen 1019057 Sharper Image: 1019058 Face Pen 3 in 1 1019058 Sharper Image: 1019056 Light Therapy Visor 1019056 Blackhead Remover Massager, therapeutic, electric Eye Massager Cream Booster, Hot and cool Massager Body Massager: TB-1796 Eye massager: TB-1883 GLAM LED Facial Mask TB-2386F VITA Multi-Function Head Brush (TB-2343F, TB-2442F) IPL Goggles IPL Hair Removal Device TB-1755 Uitrasonic scrub device TB-1487M ELECTRIC FACIAL CLEANSER Massager, therapeutic, Manual Body Massager VITA Multi-Function Head Brush Model(s):TB-2443F,TB-2442AF,TB-2343F,TB2442F Water Flosser Graphene FIR Helmet TB-2546

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2018-01-03
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2021-03-16
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2022-05-17
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2018-01-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-09-05
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2026-06-08
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2018-01-01
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2020-12-30
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2020-12-30
JDX	Instrument, Surgical, Sonic And Accessory/Attachment	Orthopedic	Class 2	888.4580	2018-01-01
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2018-01-01
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-12-17
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-12-17
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2025-12-17
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2022-05-17
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2026-05-07

Official Correspondent

Catherine Zhang

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) 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
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010027944. Last updated year: 2026. Please use registration number 3010027944 when referencing this establishment in official correspondence.