FDA.reportPublic FDA data

Ciliprobe Transsceral Cyclophotocoagulation Probe

Primary DI
10817489025151
Brand
Ciliprobe Transsceral Cyclophotocoagulation Probe
Company
KATALYST SURGICAL LLC
Model
D4700A
Published
2017-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LQJLens, Surgical, Laser, Accesssory, Ophthalmic Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQJLens, Surgical, Laser, Accesssory, Ophthalmic LaserOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163632000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163632000Katalyst Cyclophotocoagulation ProbeKatalyst Surgical, LLC2017-06-15LQJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817489025151PrimaryGS10
00817489025154Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081748902515110817489025151
00817489025154008174890251548174890251540817489025154

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fibreoptic light instrument, single-useA sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007883297
Device count
5
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
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
1081748902365223ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORCV6300-23JR2020-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840096211365Cili Probes (Cyclophotocoagulation)KATALYST SURGICAL LLCLQJ2020-03-04
00840096211368Cili Probes (Cyclophotocoagulation)KATALYST SURGICAL LLCLQJ2020-03-04
10817489025298Cyclophotocoagulation Probe, Quantel ConnectorKATALYST SURGICAL LLCLQJ2018-12-11
10817489025304Cyclophotocoagulation Probe, Iridex ConnectorKATALYST SURGICAL LLCLQJ2018-12-11
10817489025168Ciliprobe Transsceral Cyclophotocoagulation ProbeKATALYST SURGICAL LLCLQJ2017-07-21