FDA.reportPublic FDA data

XLEND25MULTIFLEX

Primary DI
10840096215318
Brand
XLEND25MULTIFLEX
Company
KATALYST SURGICAL LLC
Model
XLEND25MULTIFLEX
Device description
MULTIFLEX LASER PROBE 25ga Quantel Compatible
Published
2025-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQBPhotocoagulator And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQBPhotocoagulator And AccessoriesOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121187000KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBESKatalyst Surgical, LLC2012-09-17HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840096215318PackageGS110In Commercial Distribution
00840096215311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084009621531810840096215318
00840096215311008400962153118400962153110840096215311

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic laser system beam guideA sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007883297
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0081748902202325ga Dex™ Serrated Jaw ForcepsDVF4016-252016-08-11
0081748902214625ga Dex™ Maculorhexis ForcepsDVF4019-252016-08-11
00840096207606DEX TIPS™ Universal HandleCV-Handle2020-06-08
00840096207613DEX TIPS™ Universal Slim HandleCVO-Handle2020-06-08
10840096211365Cili Probes (Cyclophotocoagulation)6202312020-03-04
10817489025298Cyclophotocoagulation Probe, Quantel ConnectorXLCYCLO2018-12-11
10817489025304Cyclophotocoagulation Probe, Iridex ConnectorXLCYCLOA2018-12-11
10817489025151Ciliprobe Transsceral Cyclophotocoagulation ProbeD4700A2017-07-21
10817489025168Ciliprobe Transsceral Cyclophotocoagulation ProbeD4700C2017-07-21
1084009621532527ga Stiff Slim DEX™ NanoTapered™ Awh ForcepsDVFO4005-272025-10-06
00840096214987Curved Up Micro Scissors, 11mm Blades, Bayonet Round Handle, 230mmN61062025-09-10
1081748902356020ga Straight Illuminated Laser Probe, 19ga Needle Illumination, IridexV6300-20AR2020-11-25
1081748902357720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconV6300-20BR2020-11-27
1081748902358420ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelV6300-20CR2020-11-27
1081748902359120ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekV6300-20ER2020-11-27
1081748902360720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORCV6300-20JR2020-11-27
1081748902361423ga Straight Illuminated Laser Probe, 19ga Needle Illumination, IridexV6300-23AR2020-11-25
1081748902362123ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconV6300-23BR2020-11-27
1081748902363823ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelV6300-23CR2020-11-27
1081748902364523ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekV6300-23ER2020-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M735A5026001NAOPHTHALMED LLCHQB2022-09-22
M735A5027001NAOPHTHALMED LLCHQB2022-09-22
M735A5036001NAOPHTHALMED LLCHQB2022-09-22
M735A5037001NAOPHTHALMED LLCHQB2022-09-22
13700773703743FLEX CURVED LASER PROBE COMPATIBLE WITH Iridex / Bausch & Lomb™ 27 G FCI S A S FCI 20 22HQB2021-05-30
13700773703750FLEX CURVED LASER PROBE COMPATIBLE WITH Alcon® / Coherent / Zeiss / Ellex / OS4®FCI S A S FCI 20 22HQB2021-05-30
13700773703767CURVED LASER PROBE, 27G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773703774FLEX CURVED LASER PROBE COMPATIBLE WITH NIDEK THREAD 27 G FCI S A S FCI 20 22HQB2021-05-30
13700773703781FLEX CURVED LASER PROBE COMPATIBLE WITH DORC 27 G FCI S A S FCI 20 22HQB2021-05-30
13700773720047STRAIGHT LASER PROBE, 20G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720054STRAIGHT LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720061STRAIGHT LASER PROBE, 20G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720078STRAIGHT LASER PROBE, 20G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720085STRAIGHT LASER PROBE, 20G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720092STRAIGHT LASER PROBE, 23G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720108STRAIGHT LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720115STRAIGHT LASER PROBE, 23G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720122STRAIGHT LASER PROBE, 23G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720139STRAIGHT LASER PROBE, 23G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720146STRAIGHT LASER PROBE, 25G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720153STRAIGHT LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720160STRAIGHT LASER PROBE, 25G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720177STRAIGHT LASER PROBE, 25G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720184STRAIGHT LASER PROBE, 25G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720191STRAIGHT LASER PROBE, 27G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720207STRAIGHT LASER PROBE, 27G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720214STRAIGHT LASER PROBE, 27G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720221STRAIGHT LASER PROBE, 27G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720238STRAIGHT LASER PROBE, 27G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720245CURVED LASER PROBE, 20G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30