FDA Registration Active 🇨🇳 China

WINGDERM ELECTRO-OPTICS LTD.

Reg #: 3014310779 · FEI: 3014310779 · Expires 2026
Products
2
Proprietary Names
2
Establishment Types
2
Classifications
2

Registration Details

Registration Name
WINGDERM ELECTRO-OPTICS LTD.
Registration Number
3014310779
FEI Number
3014310779
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Building 6, No.97 Changping Road, Changping District
City
Beijing
Country
CN

Regulatory Submissions

510(k) Number
K191611

Owner / Operator

Firm Name
Wingderm Electro-Optics Ltd.
Operator Number
10061423
Address
Building 6, No.97 Changping Road, Changping District
City
Beijing
State
CN-BJ
Postal Code
102206
Country
CN
Correspondent
Juan Zhou

US Agent

Business Name
Wingderm USA Inc.
Contact Name
Xu Ren
Address
97 E. Brokaw Rd. STE 300, San Jose, CA 95112, USA
City
San Jose
State
CA
ZIP
95112
Country
US
Phone
408 8004998

Products

Device Name Product Code
Powered Laser Surgical Instrument GEX
Powered Laser Surgical Instrument With MicrobeamFractional Output ONG

Proprietary Names

Diode Laser Therapy Systems Medical Non-ablative Fractional Laser Systems

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device