Is this your brand? Sign in to claim ownership.

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 4 of 10

Device	Model / Reference	Registries	Class	Status
Flex Curved Laser Probe, 23g Iridex/B&L	S9.1211.23	FDA UDI	Class II	Active
EXTERNAL OCULID LIGHT® - 1, 0 g	S3.60100	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	ePTFE HALF SPONGE 2.5 X 7.5 mm	FDA UDI	Class II	Active
Straight Illum Laser Probe, 23g Dorc & 19g Needle	S9.1405.23	FDA UDI	Class II	Active
FCI directional LASER PROBE / EXTENDABLE 23G QUANTEL	S9.1323.23	FDA UDI	Class II	Active
OCULID GOLD 2, 2g	S3.3022	FDA UDI	Class II	Active
Straight Illum Laser Probe, 20g Nidek & 19g Needle	S9.1404.20	FDA UDI	Class II	Active
T.curved Illum Laser Probe, 25g Quantel & 19g Needle	S9.1603.25	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	GROOVED SPONGE 3 x 5 TYPE 506 G	FDA UDI	Class II	Active
Disposable Soft Tip Cannula 25g	S9.4110.25	FDA UDI	Class I	Active
Scleral buckling device, non-bioabsorbable	FIXATION SLEEVE FOR S5.2005U TYPE 270	FDA UDI	Class II	Active
Shielded Widefield Light Probe 25g, & 19g Needle	S9.2201.25	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	STRIP (5.7 mm) TYPE 20	FDA UDI	Class II	Active
FCI directional LASER PROBE / EXTENDABLE 25G DORC	S9.1325.25	FDA UDI	Class II	Active
EXTERNAL OCULID PINK® - 0, 8 g	S3.60081	FDA UDI	Class II	Active
Disposable Backflush Handpiece	S9.3011.27	FDA UDI	Class I	Active
OCULID GOLD 0.6g	S3.3006	FDA UDI	Class II	Active
FCI directional LASER PROBE 25G IRIDEX/B&L	S9.1311.25	FDA UDI	Class II	Active
Disposable Tano Forceps 23g	S9.6017.23	FDA UDI	Class I	Active
Curved Laser Probe, 20g Iridex/B&L	S9.1101.20	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	STRIP (6 mm) TYPE 219	FDA UDI	Class II	Active
Widefield Light Probe 25g, & 19g Needle	S9.2101.25	FDA UDI	Class II	Active
Autostable Bicanaliculus Intubation Set Ii (25 Mm) With Dilator	S1.1390	FDA UDI	U	Active
Disposable Backflush Handpiece 20g, Brush Tip	S9.3011.20	FDA UDI	Class I	Active
Surgical depth gauge, reusable	PUNCTAL GAUGES FOR PLUG S2.3652U AND S2.3672U	FDA UDI	Class I	Active
Lacrimal dilator, single-use	DISPOSABLE PUNCTUM DILATOR AND PLUG INSERTER	FDA UDI	Class I	Active
Curved Laser Probe, 20g Alcon/Coherent/Zeiss/Ellex/Os4	S9.1102.20	FDA UDI	Class II	Active
Vitrectomy contact lens, single-use	DISPOSABLE PRISMATIC 30° LENS	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	ePTFE DUCOURNAU BAND 2.5 X 7.0 mm	FDA UDI	Class II	Active
EXTERNAL OCULID MEDIUM BROWN® - 1, 8 g	S3.60183	FDA UDI	Class II	Active
Lacrimal tube	MONO-CRAWFORD MEDIUM COLLARETTE B. FAYET, MD	FDA UDI	U	Active
Disposable Brush Tip Cannula 23g	S9.4111.23	FDA UDI	Class I	Active
Tano Polisher, 23g	S9.6016.23	FDA UDI	Class I	Active
EXTERNAL OCULID MEDIUM BROWN® - 0, 8 g	S3.60083	FDA UDI	Class II	Active
Ophthalmic trocar	RETILOCK® 23G VALVED SELF-RETAINING TROCAR	FDA UDI	Class I	Active
Orbital sphere implant	ENUCLEATION EVISCERATION IMPLANT Ø 13 MM	FDA UDI	Class II	Active
EXTERNAL OCULID DARK BROWN® - 1, 2 g	S3.60124	FDA UDI	Class II	Active
Disposable Backflush Handpiece 25g, Blunt Tip	S9.3012.25	FDA UDI	Class I	Active
EZYPOR® Ø 20 mm	S6.6020	FDA UDI	Class II	Active
OCULID GOLD 1, 2g	S3.3012	FDA UDI	Class II	Active
T.curved Illum Laser Probe, 23g Iridex/B&L & 19g Needle	S9.1601.23	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	SPONGE 5.5 x 7.5 TYPE 507	FDA UDI	Class II	Active
Straight Laser Probe, 23g Dorc	S9.1005.23	FDA UDI	Class II	Active
Fci Nunchaku 105	S1.1371	FDA UDI	U	Active
Lacrimal tube	MASTERKA ® 35 (DESIGNER B. FAYET, M.D.)	FDA UDI	U	Active
EXTERNAL OCULID TAN® - 1, 6 g	S3.60162	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	SPONGE 7.0 x 3.25 TYPE 907	FDA UDI	Class II	Unknown
T.curved Illum Laser Probe, 23g Dorc & 19g Needle	S9.1605.23	FDA UDI	Class II	Active
Lacrimal punctum plug	READY-SET PUNCTUM PLUG (LARGE, US 0.1)	FDA UDI	U	Active
Disposable Backflush Handpiece 23g, Brush Tip	S9.3011.23	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.