FDA Registration Active 🇰🇷 South Korea

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System

Reg #: 3012440264 · FEI: 3012440264 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1

Registration Details

Registration Name
FINEMEC Co., Ltd
Registration Number
3012440264
FEI Number
3012440264
Status
Active
Expiry Year
2025
Initial Importer
No
Address
604-1, 217, Heojun-Ro
City
Gangseo-gu Seoul
Country
KR

Regulatory Submissions

510(k) Number
K182663

Owner / Operator

Firm Name
FineMEC Co., Ltd.
Operator Number
10050037
Address
604-1, 701, 217, Heojun-Ro
City
Gangseo-gu
State
Seoul
Postal Code
07531
Country
KR

US Agent

Business Name
Registrar Corp
Contact Name
David Lennarz
Address
144 Research Drive
City
Hampton
State
VA
ZIP
23666
Country
US
Phone
757 2240177

Products

Device Name Product Code
Powered Laser Surgical Instrument GEX

Proprietary Names

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System

Establishment Types

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