Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007238544

FEI Number

3007238544

Entity Name

XIAMEN SOLEX HIGH-TECH INDUSTRIES CO.,LTD

City/State/Country

Xiamen Fujian, CN

Establishment Address

No. 82, Xiyuan Road, Haicang District, Xiamen Fujian 361022, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

XIAMEN SOLEX HIGH-TECH INDUSTRIES CO.,LTD (Owner Number: 10060751)

Owner / Operator Contact Address

No. 298 Yangguang West Road, Haicang District,, Xiamen, CN-FJ 361022, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SL108 Facial Cleansing Brush Electric toothbrush SL216 Water Flosser BellaFlash Pro; Flash & Go Pro; Light Based Over The Counter Hair Removal; Motion Premium; Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Titan Mini; Titan MultiPlatform; Silk'n Titan Allways RejuvatoneMD Manual Therapeutic Shower Massager, Power Pulse Therapeutic Strength Massage, Massage Topper

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2019-06-19
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2024-11-26
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2019-06-19
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-04-15
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2025-04-15
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2024-03-20
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2024-03-20
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2019-06-19
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2019-12-19

Official Correspondent

Yali Zheng

US Agent Details

Hui Hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

XIAMEN SOLEX HIGH-TECH INDUSTRIES CO.,LTD

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K192521	Shangdong Huamei Technology Co., Ltd.	Intense Pulsed Light Treatment System	2019-12-06

Similar Registrations

Registration Number	Establishment Name	Location
3010337012	JEAN MARIE LORENZ S.R.L.	San Mango Piemonte Campania, IT
3012170108	JET TECH EUROPE S.R.L.	Milan Milano, IT
3005450640	EUNSUNG GLOBAL CORP.	Wonju-si Gangwon, KR
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3029972466	ASTERASYS CO., LTD.	Seongdong-gu Seoul, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007238544. Last updated year: 2026. Please use registration number 3007238544 when referencing this establishment in official correspondence.