FDA Registration
Active
🇨🇳 China
DONGGUAN YANXI TECHNOLOGY CO. LTD.
Reg #: 3017618922
·
FEI: 3017618922
·
Expires 2026
Products
13
Proprietary Names
47
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- DONGGUAN YANXI TECHNOLOGY CO. LTD.
- Registration Number
- 3017618922
- FEI Number
- 3017618922
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 501, Zhigu Science and Technology Park, Tianxin Village, 19 Guanglong Road, Huangjiang Town
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K252189
Owner / Operator
- Firm Name
- Dongguan Yanxi Technology Co. LTD.
- Operator Number
- 10086613
- Address
- Room 501, Zhigu Science and Technology Park, Tianxin Village, 19 Guanglong Road, Huangjiang Town
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523857
- Country
- CN
- Correspondent
- Wenlan Wei
US Agent
- Business Name
- ANTEK SERVICE INC.
- Contact Name
- Shirley Guo
- Address
- 901 N PENNSYLVANIA ST STE 0
- City
- Denver
- State
- CO
- ZIP
- 80203
- Country
- US
- [email protected]
- Phone
- 303 8006306
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2022-11-23 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-12-22 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2022-11-23 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2022-11-23 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2022-11-23 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2022-11-23 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2023-05-25 |
| Adaptor, Grooming | ILW | Class 1 | Physical Medicine | No | 2022-11-23 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2024-11-26 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2022-11-23 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2025-09-17 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2025-09-17 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2022-11-23 |
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
LED Light Therapy Mask (2311, 2344, 2457, 2458)
Humidifier, Eye Spray device, Electronic mouth spray
Heimlich anti-choking device 2505
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)