STRAIGHT LASER PROBE, 23G IRIDEX/B&L

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: K121187

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
Email: [email protected]
Phone: 817 9258507

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Laser, Ophthalmic	HQF	Class 2	Ophthalmic	No	2016-11-04
Endoilluminator	MPA	Class 2	Gastroenterology, Urology	No	2016-11-04
Photocoagulator And Accessories	HQB	Class 2	Ophthalmic	No	2016-11-04

Proprietary Names

STRAIGHT LASER PROBE, 23G IRIDEX/B&L CURVED ILLUM LASER PROBE,20G ALC/COH/ZEISS/ELLEX/OS4&19G N. 90 DEGREE ADJUSTABLE LASER PROBES, 25GA NIDEK/LUMENIS NOVUS SPECTRA T.CURVED ILLUM LASER PROBE,23G NIDEK & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,25G IRIDEX/B&L & 19G NEEDLE STRAIGHT LASER PROBE, 25G IRIDEX/B&L STRAIGHT ILLUM LASER PROBE,20G ALC/COH/ZEISS/ELLEX/OS4&19G N. CURVED LASER PROBE, 20G NIDEK STRAIGHT LASER PROBE, 23G NIDEK CURVED LASER PROBE, 25G QUANTEL CURVED LASER PROBE, 25G NIDEK CURVED ILLUM LASER PROBE,20G IRIDEX/B&L & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,27G DORC & 19G NEEDLE STRAIGHT LASER PROBE, 20G DORC 90 DEGREE ADJUSTABLE LASER PROBES, 23GA NIDEK/LUMENIS NOVUS SPECTRA CURVED LASER PROBE, 23G IRIDEX/B&L FLEX CURVED LASER PROBE, 25G NIDEK CURVED LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4 FLEX CURVED LASER PROBE, 23G NIDEK FLEX CURVED LASER PROBE, 23G QUANTEL FLEX CURVED LASER PROBE, 25G DORC STRAIGHT ILLUM LASER PROBE,25G ALC/COH/ZEISS/ELLEX/OS4&19G N. STRAIGHT LASER PROBE, 20G IRIDEX/B&L 90 DEGREE ADJUSTABLE LASER PROBES, 25GA IRIDEX/B&L CURVED ILLUM LASER PROBE,20G NIDEK & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,27G QUANTEL & 19G NEEDLE FLEX CURVED LASER PROBE, 23G IRIDEX/B&L T.CURVED ILLUM LASER PROBE,25G DORC & 19G NEEDLE CURVED LASER PROBE, 23G QUANTEL STRAIGHT ILLUM LASER PROBE,27G ALC/COH/ZEISS/ELLEX/OS4&19G N. T.CURVED ILLUM LASER PROBE,23G DORC & 19G NEEDLE STRAIGHT LASER PROBE, 27G ALCON/COHERENT/ZEISS/ELLEX/OS4 T.CURVED ILLUM LASER PROBE,23G IRIDEX/B&L & 19G NEEDLE 90 DEGREE ADJUSTABLE LASER PROBE, 23G IRIDEX/B&L STRAIGHT LASER PROBE, 25G QUANTEL STRAIGHT ILLUM LASER PROBE,23G QUANTEL & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,27G NIDEK & 19G NEEDLE FLEX CURVED LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4 CURVED LASER PROBE, 23G NIDEK T.CURVED ILLUM LASER PROBE,23G QUANTEL & 19G NEEDLE 90 DEGREE ADJUSTABLE LASER PROBES, 23GA DORC STRAIGHT LASER PROBE, 25G DORC STRAIGHT ILLUM LASER PROBE,23G IRIDEX/B&L & 19G NEEDLE CURVED LASER PROBE, 23G DORC T.CURVED ILLUM LASER PROBE,25G IRIDEX/B&L & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,25G DORC & 19G NEEDLE FLEX CURVED LASER PROBE, 23G DORC STRAIGHT LASER PROBE, 23G DORC STRAIGHT ILLUM LASER PROBE,20G QUANTEL & 19G NEEDLE CURVED LASER PROBE, 25G DORC T.CURVED ILLUM LASER PROBE,25G QUANTEL & 19G NEEDLE CURVED LASER PROBE, 20G DORC STRAIGHT ILLUM LASER PROBE,23G ALC/COH/ZEISS/ELLEX/OS4&19G N. 90 DEGREE ADJUSTABLE LASER PROBES, 25GA DORC STRAIGHT LASER PROBE, 27G QUANTEL STRAIGHT LASER PROBE, 27G DORC FLEX CURVED LASER PROBE, 25G IRIDEX/B&L CURVED ILLUM LASER PROBE,20G DORC & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,23G DORC & 19G NEEDLE STRAIGHT LASER PROBE, 27G NIDEK STRAIGHT LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4 CURVED LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4 STRAIGHT ILLUM LASER PROBE,20G NIDEK & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,23G NIDEK & 19G NEEDLE CURVED LASER PROBE, 25G IRIDEX/B&L STRAIGHT LASER PROBE, 20G QUANTEL STRAIGHT LASER PROBE, 20G NIDEK 90 DEGREE ADJUSTABLE LASER PROBES, 23GA ALCON/COHERENT/ZEISS/ELLEX/OS4 T.CURVED ILLUM LASER PROBE,25G NIDEK & 19G NEEDLE 90 DEGREE ADJUSTABLE LASER PROBES, 25GA ALCON/COHERENT/ZEISS/ELLEX/OS4 90 DEGREE ADJUSTABLE LASER PROBES, 25GA QUANTEL STRAIGHT ILLUM LASER PROBE,25G NIDEK & 19G NEEDLE STRAIGHT LASER PROBE, 27G IRIDEX/B&L STRAIGHT LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4 STRAIGHT ILLUM LASER PROBE,25G QUANTEL & 19G NEEDLE T.CURVED ILLUM LASER PROBE,25G ALC/COH/ZEISS/ELLEX/OS4&19G N. STRAIGHT ILLUM LASER PROBE,27G IRIDEX/B&L & 19G NEEDLE T.CURVED ILLUM LASER PROBE,23G ALC/COH/ZEISS/ELLEX/OS4&19G N. 90 Degree ADJUSTABLE LASER PROBE, 23G QUANTEL FLEX CURVED LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4 STRAIGHT LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4 STRAIGHT ILLUM LASER PROBE,20G DORC & 19G NEEDLE CURVED LASER PROBE, 20G IRIDEX/B&L STRAIGHT LASER PROBE, 25G NIDEK CURVED LASER PROBE, 20G QUANTEL CURVED ILLUM LASER PROBE,20G QUANTEL & 19G NEEDLE STRAIGHT LASER PROBE, 23G QUANTEL CURVED LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4 STRAIGHT ILLUM LASER PROBE,20G IRIDEX/B&L & 19G NEEDLE FLEX CURVED LASER PROBE, 25G QUANTEL DORC Revolver Illumination Adapter FCI Directional Extendable laser probes, 23G, 25G, Compatible with DORC FCI Directional Extendable laser probes, 23G, 25G, Compatible with Iridex / Bausch+Lomb FCI Directional laser probes, 23G, 25G, Compatible with Nidek Thread FCI Directional laser probes, 23G, 25G, Compatible with Iridex / Bausch+Lomb FIBER OPTIC CONNECTOR ZEISS VISALIS FIBER OPTIC CONNECTOR ALCON-ACCURUS® AND CONSTELLATION® FCI Directional laser probes, 23G, 25G, Compatible with Dorc FCI Directional laser probes, 23G, 25G, Compatible with Alcon® / Coherent / Zeiss / Ellex / OS4® / Lightmed FCI Directional Extendable laser probes, 23G, 25G, Compatible with Alcon® / Coherent / Zeiss / Ellex / OS4® / Lightmed FCI Directional Extendable laser probes, 23G, 25G, Compatible with Quantel Supra® / Vitra® FCI Directional Extendable laser probes, 23G, 25G, Compatible with Nidek Thread FIBER OPTIC CONNECTOR BAUSCH & LOMB STELLARIS® FCI Directional laser probes, 23G, 25G, Compatible with Quantel Supra® / Vitra® FIBER OPTIC CONNECTOR COMPATIBLE WITH DORC

Establishment Types

Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device