FDA Registration
Active
🇨🇳 China
SHENZHEN SUNGROW LED TECHNOLOGY CO.,LTD
Reg #: 3016171836
·
FEI: 3016171836
·
Expires 2026
Products
6
Proprietary Names
18
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- SHENZHEN SUNGROW LED TECHNOLOGY CO.,LTD
- Registration Number
- 3016171836
- FEI Number
- 3016171836
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3F, 2# Factory Bldg (Phase I), Bangkai Sci & Tech Ind Park, Guangming High-Tech Ind Park
- City
- shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K250830
Owner / Operator
- Firm Name
- Shenzhen Sungrow LED Technology Co.,LTD
- Operator Number
- 10061584
- Address
- 3F, 2# Factory Bldg (Phase I), Bangkai Sci & Tech Ind Park, Guangming High-Tech Ind Park
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518132
- Country
- CN
- Correspondent
- SenHua Liu
US Agent
- Business Name
- Purelux Tech INC
- Contact Name
- Yafen Zhang
- Address
- 19742 MacArthur Blvd, Ste 145
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
- [email protected]
- Phone
- 949 8166662
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2019-10-31 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2019-10-31 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2024-10-20 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2025-06-13 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2025-06-13 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2022-12-08 |
Proprietary Names
Eye Mask (EM01, EM02, EM03, EM04, EM05, EP01, EP02, LP01, LP02)
BlockBlueLight MEGA, BlockBlueLight ELITE XL, BlockBlueLight ULTIMATE XXL, BlockBlueLight MEGA PLUS, MitoPRO X series,
BlockBlueLight PORTABLE, BlockBlueLight TABLETOP, BlockBlueLight MID, BlockBlueLight PRO, BlockBlueLight MAX,
G16, G17, G18, G19, G20, G11V2, G240, G56, G66, G120, G260, G280, G288, G300, G360, G480, G1280, G1980, G2030, G3040,
G3060, Combo Mask, BBL-FACEMASK, VISO, PRANA, ChinChest, SP01
LumaGlow Duo, LumaGlow Computer Light Bar, X 1500w, S 300w, MINI, G06, G10, G11, G11P, G12, G13, G14, G15, G15P, G15K,
MitoPRO 300X, MitoPRO 750X, MitoPRO 1500X, MitoPRO MEGAX, MitoPRO ELITEX, MitoPRO ULTIMATEX, PRO300, PRO750, PRO1500,
ESPLUS360, ESPLUS750, ESPLUS1500, ESPLUS4500, ESPLUS5400, SL280, S300, S750, S1500, A300, A600, A1200, E300, E600, E900,
PRO4500, HG200, HG300, HG500, HG1000, HG1500, ULTRA360, ULTRA750, ULTRA1500, ULTTRA4500, 2-54, 2-360, 2-720, 2-1020,
E1500, E1800, E2400, E4500, MAX300, MAX900, MAX1800, MAX4800, MINI60PRO, MATEPRO75, PRO200, P40A, P40B, P40MAX, BK200,
2-2040, 4-54, 4-360, 4-720, 4-1020, 4-2040, 5-54, 5-560, 5-1040, 5-1440, 5-2520, 5-6120, LP-RJVGLW-WHT, LumaGlow,
BK300, BK900, BK1800, MINI60S, SPRO200, SPRO300, MZ01, MZ02, S009-001, S009-002, S009-003, BlockBlueLight MINI,
HG04, HG06)
Beauty Device (MY01, MY02, MY24, MS01, MS02, MS03, MS04, C01, C02, C03, HC03, HC04, T01, T02, T03, T04, HG02, HG03,
LED Light Therapy Mask (models: G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
Belt, Red Light Belt, LED Red Light Belt, LED Light Mat: (BE-G122, BE120, BE120P, BE105P, BE105, BE405, BE150, L01, L02,
L03, L04, L05, L06, D01, D02, D03, D04, D05, D06, BE400, BE700, PC01, PC02, PC03, PC04);
Pad, Mat, PEMF Mat, Heating Mat: (PE01, PE02, PE03, PE04)
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device