Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016214547

FEI Number

3016214547

Entity Name

RED DOT LED LIGHTING LIMITED

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

10th Floor,No.3 Factory,No.128 Shangnan Dong Lu, Huangpu Community, Xinqiao Street, Bao'an District, Shenzhen Guangdong 518125, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

E.SHINE SYSTEMS LIMITED (Owner Number: 10086058)

Owner / Operator Contact Address

9th-10th Floors, Building 3, No.128 Shajing Shangnan East Road, Huangpu Community, Xinqiao Street, Bao'an District, Shenzhen, CN-GD 518125, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bio Light S2, Bio Light S3, Bio Light S4, Bio Light S5, Bio Light S6, Bio Light U1 THERAPY LIGHT; EST-T1, EST-T2, EST-H1, EST-X2, RD60, RD500, RD1000, RD1500, RDMAX, RD6000 RDPRO300, RDPRO750 HG01, HG02, HG07, HAPPYHAT, RDXR300, RDXR750, RDXR1500, RDXR3000, RDXR6000 RDPRO900, RDPRO1000, RDPRO1500, RDPRO3000, RDPRO5000, RDPRO6000, SAUNAONE, SD049, YD002, YD001, YD004 YD007, WL-VS17, YS018, YD003, YD006, YD007, YD008, YD009 YD010, Bio Light S1 PRO-01, MINI-01, Switch M1, Switch M2, Switch M3, Refine 180, Refine 360, Refine 900, Refine 1800, Refine 3600 M226, RDPRO MINI, RedAura Shower One, VitalGlow One, Apex 1500, Apex 750, Apex 2160, YD056, YD035, Hat-01 Bio Light U2, Bio Light U3, Bio Light U4, Bio Light U5, Bio Light U6, Bio Light Mini, Bio Light Focus RDPRO300 ULTRA, RDPRO750 ULTRA, RDPRO1500 ULTRA, RDPRO900 ULTRA, RDPRO3000 ULTRA, RDPRO6000 ULTRA YM1011, YM1013, RLF300, RLF750, RLF1500, RLF3000, RLF6000, F2, CS-001, F8, F18, F10, F12, F88, F68, E49

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2022-10-13

Official Correspondent

Baiying Li

US Agent Details

Eric Pang Email: ericpang31@hotmail.com Phone: (626) 3425538

Related Public Records

Same Entity

E.SHINE SYSTEMS LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016214547. Last updated year: 2026. Please use registration number 3016214547 when referencing this establishment in official correspondence.