BEIJING ADSS DEVELOPMENT CO., LTD.

FDA Device Registration & Listing · Beijing, CN · Registration 3007084556

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007084556
FEI Number
3007084556
Entity Name
BEIJING ADSS DEVELOPMENT CO., LTD.
City/State/Country
Beijing, CN
Establishment Address
Room 609, F6, Building 13,, Yard 5 Tianhua Street Daxing District, Beijing 102600, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Beijing ADSS Development Co., Ltd. (Owner Number: 10053130)
Owner / Operator Contact Address
Room 609, F6, Building 13, Yard 5 Tianhua Street,, Daxing District,, Beijing, CN-BJ 102600, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231318
PMA Number
N/A

All Registered Proprietary Names

Picosecond Laser System (PS10-A, PS10-B) Fractional CO2 Laser Therapy System (FG900-S,FG900-S2,PhantomClear) Aqua Facial Aphrona LED facial mask Skin analyzer; ViewSkin 3D-SK 4D-SK Diode Laser Therapy System Intensity Pulsed Light Therapy System Therapeutic electric massager ND YAG Q-Switch Laser Therapy Machine FG2010 FG2010-B FG2014 Electromagnetic Stimulator Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-10-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-12-23
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 2019-09-01
OLP Over-The-Counter Powered Light Based Laser For Acne General, Plastic Surgery Class 2 878.4810 2020-05-18
OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery Class 2 878.4810 2020-05-18
HCJ Device, Skin Potential Measurement Neurology Class 2 882.1560 2021-03-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-03-04
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2024-04-18
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2026-06-10
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2017-03-12
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2023-10-24

Official Correspondent

Ying Song

US Agent Details

Chen Yao Business: Alura Inc Email: ira@adss.com.cn Phone: (832) 9627199

Related Public Records

Same Entity

Beijing ADSS Development 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
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

Similar Registrations

Registration Number Establishment Name Location
3014980477 ELEMENIC CO., LTD. Seoul, KR
3009462521 Oncore Manufacturing, LLC dba NEOTech Fremont, CA, US
3033905238 BEIJING MEGA BEAUTY TECHNOLOGY CO.,LTD. Beijing, CN
3014384451 LAMEDITECH CO., LTD. Seoul, KR
3010273372 WEIFANG KM ELECTRONICS CO., LTD Weifang Shandong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007084556. Last updated year: 2026. Please use registration number 3007084556 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.