FDA Registration
Active
🇨🇳 China
SHENZHEN YIGUANGNIAN INNOVATION TECHNOLOGY CO., LTD.
Reg #: 3013521677
·
FEI: 3013521677
·
Expires 2026
Products
13
Proprietary Names
66
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- SHENZHEN YIGUANGNIAN INNOVATION TECHNOLOGY CO., LTD.
- Registration Number
- 3013521677
- FEI Number
- 3013521677
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 504, Creative Building, Minle Science Park, Minzhi Street, Longhua District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K231595
Owner / Operator
- Firm Name
- Shenzhen YiGuangNian Innovation Technology Co., Ltd.
- Operator Number
- 10054588
- Address
- 504, Creative Building, Minle Science Park, Minzhi Street, Longhua District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2020-09-24 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2024-05-21 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2017-04-05 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2020-09-24 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2017-04-05 |
| Cleaner, Denture, Mechanical | JER | Class 1 | Dental | No | 2017-04-05 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2017-04-05 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2020-03-05 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2020-03-05 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2017-04-05 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2017-04-05 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2017-04-05 |
| Adaptor, Grooming | ILW | Class 1 | Physical Medicine | No | 2018-05-10 |
Proprietary Names
Professional Light Teeth Whitening Kit XPRE067 XPRE136, Blue light teeth whitening device
Heat Source For Bleaching Teeth-Professional Light Teeth
BE LUCENT STELLAR XPRE170 XPRE137 XPRE067 XPRE153
Whitening Kit XPRE137; Professional Light Teeth Whitening:XPRE137
XPRE170P Professional Light stellar
XPRE458,XPRE461-Blue Light Teeth Whitening Device; Whitening Kit
Whitening:XPRE153,XPRE170; Professional Light Teeth
XPRE459 Teeth Whitening Kit
Electric breast pump with models MY-371,MY-372,MY-373,MY-375,MY-376,MY-378,MY-379,MY-380, V3
Electric Toothbrush XPRE012 XPRE132 XPRE144 XPRE145 XPRE035
stellar
XPRE423 Lazy electric toothbrush
Oral Irrigator XPRE131 VCLL822
Toothbrush
Cleaner, Denture, Mechanical - Electric Tooth Cleaner:XPRE151,XPRE152,XPRE174;
XPRE128 Electric Tooth Cleaner, IFAN059-IFAN060 XPRE151 XPRE174 Electric Tooth Cleaner
Electric Tooth Cleaner XPRE176, Electric Tooth Cleaner XPRE178 Electric Ear Cleaner XPRE323 XPRE330
Teeth Cleaner XPRE146 IFAN042; XPRE058 Makeup Brush Cleanser,XPRE127 Electric Tooth Cleaner,
XPRE467 Heating Facial Cleansing Brush
XPRE466 XPRE519 Heating Facial Cleansing Brush
Brush:XPRE171; Heating Facial Cleansing Brush:XPRE158;
Brush, Dermabrasion, Powered-Facial Cleansing
XPRE329 XPRE419 Facial Cleansing Brush
XPRE429,SHIN100 Rotating facial cleanser
XPRE333;XPRE171;Heating Facial Cleansing Brush;XPRE419;360 degree high-frequency vibration rotating facial cleanser
XPRE049 Facial Cleansing Brush,XPRE119 Heating Facial Cleansing Brush,XPRE120 Mini Facial Cleansing Brush
Infusing Beauty Device:XPRE122 XPRE321; Facial Cleansing Brush,XPRE158 Mini Facial Cleansing Brush
XPRE435,XPRE439Heating Facial Cleansing Brush
XPRE430 XPRE435A XPRE435B XPRE439 SHIN100 Heating Facial Cleansing Brush
XPRE501 Photon eye beauty device for removing eye bags
XPRE432 XPRE434 XPRE436 XPRE442 XPRE445 XPRE448 XPRE450 XPRE451 Light Therapy Device
LF 100 LF 100B LF 100PK LF 100PP XPRE502 3D light mask XPRE505 XPRE506 XPRE507 XPRE509 Light Therapy Device
Led Light Source-Rechargeable Nail Lamp:XPRE156,XPRE157,XPRE322;
XPRE322 ;XPRE326; XPRE327 Light Therapy Device
XPRE342;XPRE420;XPRE421;XPRE422 Light Therapy Device
XPRE017 Nail Lamp,XPRE018 Rechargeable Nail Lamp,XPRE052 Wireless Acne Light Therapy Device
XPRE368,XPRE422 Light Therapy Device, XPRE426,XPRE427 Phototherapy knee protector
Rechargeable Nail Lamp,XPRE123 XPRE062 XPRE063 XPRE052 XPRE320 Wireless Acne Light Therapy Device
EMS and RF facial import and export massage instrument XPRE173 XPRE191;
XPRE441,XPRE453 Wireless Acne Light Therapy Device, XPRE449,XPRE455,XPRE458,XPRE460 XPRE462 Light Therapy Device
Orthosis, Thoracic-ITGH808B Posture Corrector
ITGH803 Posture Corrector
XPRE433 Atomizing comb XPRE443 Electric eyebrow trimming instrument XPRE446 XPRE449 Hair growth hat
XPRE121Rechargeable Eyebrow Remover; XPRE124 Mini Eyebrow Remover,XPRE125 Mini Nose Hair Trimmer
XPRE126 Electric Hair Remover
Eyebrow Remover; XPRE139 XPRE134
XPRE001 XPRE009 Nose Hair Trimmer,XPRE034 Back Hair Shaver,XPRE073 Mini Hair Remover; XPRE078 Electric Eyebrow Remover
XPRE325 Personal Care Curling Stick
Personal care curling stick XPRE141, Personal care straight hair stick XPRE135
XPRE203 Eyebrow Remover,XPRE205 XPRE206 Facial Skin Scraper
XPRE115 Ion Cleansing & Infusing & Cooling Device
XPRE122 XPRE321 Ion Cleansing & Infusing Beauty Device;
Heating Facial Cleansing Brush; XPRE114 Ion Cleansing & Infusing Beauty Device,
Humidifier, Non-Direct Patient Interface (Home-Use) - Heating Facial Cleansing Brush;
XPRE418;Ion Cleansing & Infusing & Cooling Device
XPRE464 Ion Cleansing &Infusing Beauty Device, XPRE469 RF generator
XPRE440 Electric - Massager XPRE444 Bathing massager XPRE447 Rechargeable Eye Massager
XPRE468 Hair generator
Massager, therapeutic, electric - EMS and RF eye massage instrumentXPRE168 XPRE186 XPRE319
XPRE116 Rechargeable Eye Massager, XPRE118 Eye Massager
XPRE130 Electric - Massager
XPRE425,XPRE456-Rechargeable Eye Massager
Wireless Blackhead Remover,; XPRE052 Wireless Acne Light Therapy Device XPRE111 Blackhead Remover With LED Screen
Blackhead Remover XPRE129 XPRE143 XPRE133; XPRE027 XPRE202 XPRE037 XPRE113
XPRE431 XPRE441 Facial Acne Patch
XPRE508 Suction facial lifting device
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device