FDA Registration Active 🇫🇷 France

LASER PROBES, 20GA STRAIGHT TIP IRIDEX/BAUSCH & LOMB

Reg #: 3002991496 · FEI: 3002991496 · Expires 2025
Products
1
Proprietary Names
44
Establishment Types
1
Classifications
1

Registration Details

Registration Name
FCI FRANCE CHIRURGIE INSTRUMENTATION
Registration Number
3002991496
FEI Number
3002991496
Status
Active
Expiry Year
2025
Initial Importer
No
Address
20-22 RUE LOUIS ARMAND
City
PARIS Ile-de-France
Country
FR

Regulatory Submissions

510(k) Number
K021696

Owner / Operator

Firm Name
Carl Zeiss Meditec, Inc.
Operator Number
9053564
Address
5300 Central Parkway
City
Dublin
State
CA
Postal Code
94568
Country
US

US Agent

Business Name
CARL ZEISS MEDITEC USA, INC.
Contact Name
Paul Swift
Address
5300 Central Parkway
City
Dublin
State
CA
ZIP
94568
Country
US
Phone
817 9258507

Products

Device Name Product Code
Powered Laser Surgical Instrument GEX

Proprietary Names

LASER PROBES, 20GA STRAIGHT TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 23GA CURVED TIP DORC LASER PROBES, 23GA STRAIGHT TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 23GA FLEXIBLE CURVED TIP QUANTEL LASER PROBES, 23GA STRAIGHT TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 23GA STRAIGHT TIP DORC LASER PROBES, 25GA FLEXIBLE CURVED TIP ALCON/COHERENT/ZEISS/ELLEX/0S4 LASER PROBES, 20GA STRAIGHT TIP QUANTEL LASER PROBES, 25GA CURVED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 23GA CURVED TIP ALCON/COHERENT/ZEISS/0S4 LASER PROBES, 20GA CURVED TIP QUANTEL LASER PROBES, 23GA STRAIGHT TIP QUANTEL LASER PROBES, 23GA CURVED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 25GA FLEXIBLE CURVED TIP QUANTEL LASER PROBES, 25GA STRAIGHT TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 23GA STRAIGHT TIP ALCON/COHERENT/ZEISS/0S4 LASER PROBES, 23GA FLEXIBLE CURVED TIP DORC LASER PROBES, 25GA STRAIGHT TIP DORC LASER PROBES, 25GA STRAIGHT TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 25GA STRAIGHT TIP ALCON/COHERENT/ZEISS/0S4 LASER PROBES, 25GA FLEXIBLE CURVED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 25GA CURVED TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 23GA FLEXIBLE CURVED TIP ALCON/COHERENT/ZEISS/ELLEX/0S4 LASER PROBES, 20GA CURVED TIP DORC LASER PROBES, 25GA CURVED TIP DORC LASER PROBES, 25GA CURVED TIP ALCON/COHERENT/ZEISS/0S4 LASER PROBES, 25GA STRAIGHT TIP QUANTEL LASER PROBES, 27GA STRAIGHT TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 27GA STRAIGHT TIP QUANTEL LASER PROBES, 27GA STRAIGHT TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 23GA FLEXIBLE CURVED TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 20GA STRAIGHT TIP DORC LASER PROBES, 25GA FLEXIBLE CURVED TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 23GA CURVED TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 23GA CURVED TIP QUANTEL LASER PROBES, 25GA CURVED TIP QUANTEL LASER PROBES, 20GA STRAIGHT TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 20GA CURVED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 23GA FLEXIBLE CURVED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 27GA STRAIGHT TIP ALCON/COHERENT/ZEISS/0S4 LASER PROBES, 27GA STRAIGHT TIP DORC LASER PROBES, 20GA CURVED TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 25GA FLEXIBLE CURVED TIP DORC LASER PROBES, 20GA STRAIGHT TIP ALCON/COHERENT/ZEISS/0S4

Establishment Types

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