Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013995763

FEI Number

3013995763

Entity Name

SHENZHEN HANHUA OPTO CO., LTD.

City/State/Country

shenzhen Guangdong, CN

Establishment Address

5F, Building A, YIshida Bao Yicheng Science and Technology park, Guanlan Street, Longhua District, Shenzhen, shenzhen Guangdong 518000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Hanhua Opto Co., Ltd. (Owner Number: 10083913)

Owner / Operator Contact Address

5F, Building A, YIshida Bao Yicheng Science and Technology park, Guanlan Street, Longhua District, Shenzhen, shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253874

PMA Number

N/A

All Registered Proprietary Names

HP1800PRO FP300 FP300PLUS-STAND YD120 FP1000 AP1100A RLBE25 CP459PRO RH110 ZJ03 YD156 FP1500 BP180 HP1200PRO AP1800 HP6000 AP300 YD1540 ZJ02 RLBE26 RH88 ZJ04 AP1200 HP600 PRO C0B236 YD198 FP150PLUS YD4180 COB248 YD240 FP300PLUS YD3264 YD360 ZJ01 COB1320 AP600

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	2026-03-27
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2026-03-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Shenzhen Hanhua Opto Co., Ltd.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3016214547	RED DOT LED LIGHTING LIMITED	Shenzhen Guangdong, CN
3014296246	PHOTON THERAPY SYSTEMS (PTY) LTD	Pretoria Gauteng, ZA
3033920804	CHONGQING YUYI TECHNOLOGY., CO., LTD.	Chongqing, CN
3015466811	REV-MED INC.	Yongin-si Gyeonggi, KR
3035879449	DONGGUAN JIAYU ELECTRICAL CO.,LTD	Dongguan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013995763. Last updated year: 2026. Please use registration number 3013995763 when referencing this establishment in official correspondence.