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FCI S A S FCI 20 22

Last updated May 24, 2026

What FCI S A S FCI 20 22 makes

The manufacturer produces ophthalmic laser system beam guides, including curved and tapered illuminated probes for various gauge needles, designed for precision laser applications in eye surgery. Their portfolio also includes external and implantable eyelid weights, such as the Symblepharon Ring and External Occluders in different weights and colors, as well as non-bioabsorbable scleral buckling devices for retinal repair. Additional products encompass vitrectomy fluid/gas handling handpieces and cannulas, lacrimal tubes and punctum plugs for tear duct management, and orbital sphere implants for prosthetic eye applications. The company also supplies single-use vitrectomy contact lenses and adhesive strips for surgical site management.

The device portfolio is regulated under FDA’s UDI system, with products classified as Class I, Class II, and Unclassified (U). These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States, adhering to applicable domestic regulatory requirements for each device class.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: fci-ophthalmics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-932-4202
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 763408366

Catalogue (455)

Page 2 of 10

Device	Model / Reference	Registries	Class	Status
Bika Bicanalicular Intubation Set J.a. Bernard, M.d.	S1.1000	FDA UDI	U	Active
EXTERNAL OCULID TAN® - 1, 8 g	S3.60182	FDA UDI	Class II	Active
EXTERNAL OCULID TAN® - 0, 6 g	S3.60062	FDA UDI	Class II	Active
OCULID GOLD 1, 2g	S3.3012	FDA UDI	Class II	Active
FCI directional LASER PROBE 23G ALCO/COH/ZEISS/ELLEX/OS4	S9.1312.23	FDA UDI	Class II	Active
T.curved Illum Laser Probe, 23g Nidek & 19g Needle	S9.1604.23	FDA UDI	Class II	Active
pince super grip 23G	S9.6018.23	FDA UDI	Class I	Active
OCULID PLATINUM SLIM® 1, 6 g	S3.6016	FDA UDI	Class II	Active
90° Adjustable Laser Probe, 23g Alcon/Coherent/Zeiss/Ellex/Os4	S9.1302.23	FDA UDI	Class II	Active
Flex Curved Laser Probe, 23g Quantel	S9.1213.23	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	FIXATION SLEEVE FOR S5.1025U TYPE 72	FDA UDI	Class II	Active
Flex Curved Laser Probe Compatible With Dorc 27 G	S9.1215.27	FDA UDI	Class II	Active
Lacrijet® 30	S1.1530	FDA UDI	U	Active
Tano Forceps 27 G	S9.6017.27	FDA UDI	Class I	Active
EXTERNAL OCULID MEDIUM BROWN® - 1, 4 g	S3.60143	FDA UDI	Class II	Active
OCULID GOLD 2, 8g	S3.3028	FDA UDI	Class II	Active
Orbital sphere implant	EGG SHAPED BIOCERAMIC ORBITAL IMPLANT DIA. 20 MM	FDA UDI	Class II	Active
Straight Laser Probe, 25g Quantel	S9.1003.25	FDA UDI	Class II	Active
Straight Illum Laser Probe, 25g Dorc & 19g Needle	S9.1405.25	FDA UDI	Class II	Active
FCI directional LASER PROBE / EXTENDABLE 25G ALCO/COH/ZEISS/ELLEX/OS4	S9.1322.25	FDA UDI	Class II	Active
90° Adjustable Laser Probe, 25g Nidek	S9.1304.25	FDA UDI	Class II	Active
TearSaver® - 0.8 mm	S2.3882	FDA UDI	U	Active
Lacrimal tube	PVP MONO-CRAWFORD MEDIUM COLLARETTE B. FAYET, MD	FDA UDI	U	Active
OCULID PLATINUM SLIM® 1, 0 g	S3.6010	FDA UDI	Class II	Active
Orbital sphere implant	MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (18 mm)	FDA UDI	Class II	Active
Lacrimal tube	MINI MONOKA ® FAYET & BERNARD ®	FDA UDI	U	Active
Orbital sphere implant	ENUCLEATION EVISCERATION IMPLANT Ø 12 MM	FDA UDI	Class II	Active
Lacrimal tube	PVP SELF-THREADING MONOKA FAYET, BERNARD, RITLENG	FDA UDI	U	Active
Disposable Soft Tip Cannula 20g	S9.4110.20	FDA UDI	Class I	Active
Straight Laser Probe, 20g Quantel	S9.1003.20	FDA UDI	Class II	Active
EZYPOR® Ø 22 mm	S6.6022	FDA UDI	Class II	Active
FCI directional LASER PROBE 23G NIDEK	S9.1314.23	FDA UDI	Class II	Active
EXTERNAL OCULID LIGHT® - 0, 6 g	S3.60060	FDA UDI	Class II	Active
FCI directional LASER PROBE / EXTENDABLE 25G IRIDEX/B&L	S9.1321.25	FDA UDI	Class II	Active
Lacrimal punctum plug	PUNCTUM PLUGS - MICRO PACK (MICRO, 0.6) J. A. BERNARD, M.D.	FDA UDI	U	Active
EXTERNAL OCULID DARK BROWN® - 1, 0 g	S3.60104	FDA UDI	Class II	Active
Disposable Maculorhexis Forceps, 25g	S9.6012.25	FDA UDI	Class I	Active
Disposable Backflush Handpiece 23g, Diamond Dusted Soft Tip	S9.3013.23	FDA UDI	Class I	Active
FCI directional LASER PROBE / EXTENDABLE 25G NIDEK	S9.1324.25	FDA UDI	Class II	Active
OCULID GOLD 1, 0g	S3.3010	FDA UDI	Class II	Active
Sphere Introducer	S6.3050	FDA UDI	Class I	Active
Disposable Serrated Forceps 23g	S9.6011.23	FDA UDI	Class I	Active
Orbital sphere implant	BIOCERAMIC ORBITAL IMPLANT Ø 17 mm	FDA UDI	Class II	Active
Orbital sphere implant	BIOCERAMIC ORBITAL IMPLANT Ø 19 mm	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	ASYMMETRICAL TIRE 12 TYPE 280	FDA UDI	Class II	Active
Curved Illum Laser Probe, 20g Alc/Coh/Zeiss/Ellex/Os4&19g N.	S9.1502.20	FDA UDI	Class II	Active
Straight Illum Laser Probe, 27g Iridex/B&L & 19g Needle	S9.1401.27	FDA UDI	Class II	Active
OCULID PLATINUM SLIM® 0, 6 g	S3.6006	FDA UDI	Class II	Active
90° Adjustable Laser Probe, 25g Iridex/B&L	S9.1301.25	FDA UDI	Class II	Active
Disposable Vertical Scissors, 25g	S9.6015.25	FDA UDI	Class I	Active

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