Wingderm Electro-Optics Ltd.

Manufacturer and brand owner in Beijing, China. 2 device types, 4 products catalogued, 3 clearances.

Registry build 21.09.26

Wingderm Electro-Optics Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Powered Laser Surgical Instrument, Powered Laser Surgical Instrument With MicrobeamFractional Output. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.

2device types registered with the FDA
4products catalogued under its own name
3510(k) clearances
2recalls

Registration

FDA registration record for Wingderm Electro-Optics Ltd.
Registered name WINGDERM ELECTRO-OPTICS LTD.
Status Registered
Registration expires 2026
Registration number 3014310779
FEI number 3014310779
DUNS 554510960
Establishment type Manufacturer, Exporter

Chinese Registration

Chinese company register details for Wingderm Electro-Optics Ltd.
Chinese legal name 北京翼美云动光电科技有限公司
Unified social credit code 91110114MA01N1HD02
Source NMPA UDI database

Location

Address of Wingderm Electro-Optics Ltd.
City Beijing
Province Beijing
Address Building 6, No.97 Changping Road, Changping District
Postal code 102206
Country China

What It Makes

Device types Wingderm Electro-Optics Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Powered Laser Surgical Instrument Class 2 Diode Laser Therapy Systems 2019 92
Powered Laser Surgical Instrument With MicrobeamFractional Output Class 2 Medical Non-ablative Fractional Laser Systems 2020 12

Own-Brand Listings

Devices catalogued by Wingderm Electro-Optics Ltd.
Product Code Catalogue numbers
Lasermach GEX 9
Lasermach PRO Handpiece GEX 3
Renuva 1550 ONG 1
Lasermach PRO GEX 1

Clearances

510(k) clearances naming Wingderm Electro-Optics Ltd. or its listings
Clearance Decision date Product code Route Held by
K252599 2026-02-24 GEX Traditional This company
K192350 2020-04-30 ONG Traditional This company
K191611 2019-07-31 GEX Traditional This company

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls naming Wingderm Electro-Optics Ltd.
Initiated FDA class Root cause Reason
2024-08-23 Class II Radiation Control for Health and Safety Act Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
2024-08-23 Class II Radiation Control for Health and Safety Act All model WLA-01 systems sold to US customers are found to have labeling non-compliances

From the Company

Published by the company on its own website, not by the FDA.

Information published by Wingderm Electro-Optics Ltd.
Main products Intelligent optoelectronic medical aesthetic equipment
Certifications FDA, CE, EAC, ANVISA, CMDCAS, TGA
Export markets Europe, America, Middle East

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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
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