Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017618922

FEI Number

3017618922

Entity Name

DONGGUAN YANXI TECHNOLOGY CO. LTD.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 501, Zhigu Science and Technology Park, Tianxin Village, 19 Guanglong Road, Huangjiang Town, Dongguan Guangdong 523857, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Dongguan Yanxi Technology Co. LTD. (Owner Number: 10086613)

Owner / Operator Contact Address

Room 501, Zhigu Science and Technology Park, Tianxin Village, 19 Guanglong Road, Huangjiang Town, Dongguan, CN-GD 523857, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Meiyan instrument, Yi moxibustion V-face beauty device 2206, 2228, 2013 Neck & Face Massager 2527, 2032, 2248, 2239 Thin face instrument, Heated eyelash curler, Eye massager, Massager, V face beautifier, Neck beautifying instrument Face and Neck Massage 2601, 2603 Cervical massage pillow 2442 Eye Massage F198 Microcurrent facial device AG1031 Face and neck beauty massage L12, L13 Eye massager 2518, Shaping instrument 2526, Beauty Wand 2530 RP hair comb 2445 Face Massager (2603) Neck massager 2527 Red Light Eye Mask 2552 Water flosser 2535 VacuLift VacuLift Trio, VacuLift Duo, VacuLift Cryo, VacuLift Plus, VacuLift Pro, VacuLift Neo NeoBack (NeoBack Air), SpectraWrap (SpectraWrap S2, SpectraWrap S4), NeoBack NeoBack Air, NeoBack S1, NeoBack S2, NeoBack S3, NeoBack S4, NeoBack S5 Red Light Massage Pillow (2571) LED Light Therapy Mask (SpectraMask Ice, PhotonMask II, 2606), Red Light Sleeping Blanket (HL2501, HL2502, HL2503), Convertta Depuffing Wand F688 V-face beauty device 2547, Blackhead remover 2309, 2449 Facial Beauty Device 2559, Cold and hot beauty device 2556 Facial brush, Skin scrubber Ultrasonic Facial Cleaning Brush F569 Ultrasonic Beauty Device F688 Handheld ultrasonic dental cleaner 2568 Facial cleansing brush F518, F528, F529, F518C, F519, F538, C11 Warm hands treasure Electric eyebrow trimmer, Nano spray Electric toothbrush, Electric washer, Children's electric toothbrush, Tooth cleaner, teeth cleaning Handheld ultrasonic dental cleaner 2368, 2113, 2058, 2366, 2361, 2366, 2390, 2274, 2339, 2366, 2338, 2168, 2166 LED Light Therapy Mask 2458, 2509, 2514, 2517, 2525, 2508, 2529, LED neck beauty device 2519 NeoNeck (NeoNeck Air, NeoNeck Lite) microcurrent facial device 2352, Beauty Light Therapy Mask 2344 NeoNeck Wave LED Light Therapy Mask 2528, 2531, 2536, 2539 Red Light Eye Mask 2342 Eye Spectral Beauty Eye Meter 2342 LED Spectrum Mask Instrument LED Light Therapy Mask 2563 LED Light Therapy Mask 2546 4D Spectrum Mask Maker 2457, Spectral Therapy Mask 2525 Photon whitening and rejuvenation instrument 2363 Milk brightening instrument 2328 LED Teeth Whitening kit WT616, WT618, YJK035 Blackhead remover, Beauty inducer, Cosmetic oxygen injector Electric Ear Cleaner 2415 Ear cleaner 2456 Heating neckerchief, Heating belt, Heated KNEEPAD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-11-23
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-12-22
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2022-11-23
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2022-11-23
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2022-11-23
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2022-11-23
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2023-05-25
ILW	Adaptor, Grooming	Physical Medicine	Class 1	890.5050	2022-11-23
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2024-11-26
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2022-11-23

Official Correspondent

Wenlan Wei

US Agent Details

Shirley Guo Business: ANTEK SERVICE INC. Email: info@antekservice.com Phone: (303) 8006306

Related Public Records

Same Entity

Dongguan Yanxi 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017618922. Last updated year: 2026. Please use registration number 3017618922 when referencing this establishment in official correspondence.