FDA.reportPublic FDA data

MaxiFlex Holmium Laser Fiber

Primary DI
B324MF400BHT0
Brand
MaxiFlex Holmium Laser Fiber
Company
MAXIFLEX, LLC
Model
MF 400BH T
Device description
365 micron Holmium Laser Fiber with SMA 905 connector for Trimedyne lasers.
Published
2016-09-24
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
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013300000MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEMTechnology Delivery Systems, Inc.2002-04-16GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B324MF400BHT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Urogenital surgical laser system beam guide, single-useA sterile, flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, and ureteral conditions (e.g., tumours, condylomas); it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter550Micrometer

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
198887072
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B324MF1000BH0MaxiFlex Holmium Laser Fiber MF 1000BH 2016-09-24
B324MF1000BHC0MaxiFlex Holmium Laser Fiber MF 1000BH C2016-09-24
B324MF1000BHD0MaxiFlex Holmium Laser Fiber MF 1000BH D2016-09-24
B324MF1000BHN0MaxiFlex Holmium Laser Fiber MF 1000BH N2016-09-24
B324MF1000BHT0MaxiFlex Holmium Laser Fiber MF 1000BH T2016-09-24
B324MF200BHHPX0MaxiFlex Holmium Laser Fiber MF 200BH HPX2016-09-24
B324MF200BHHPXC0MaxiFlex Holmium Laser Fiber MF 200BH HPX C2016-09-24
B324MF200BHHPXD0MaxiFlex Holmium Laser Fiber MF 200BH HPX D2016-09-24
B324MF200BHHPXN0MaxiFlex Holmium Laser Fiber MF 200BH HPX N2016-09-24
B324MF200BHHPXT0MaxiFlex Holmium Laser Fiber MF 200BH HPX T2016-09-24
B324MF400BH0MaxiFlex Holmium Laser Fiber MF 400BH 2016-09-24
B324MF400BHC0MaxiFlex Holmium Laser Fiber MF 400BH C2016-09-24
B324MF400BHD0MaxiFlex Holmium Laser Fiber MF 400BH D2016-09-24
B324MF400BHN0MaxiFlex Holmium Laser Fiber MF 400BH N2016-09-24
B324MF600BH0MaxiFlex Holmium Laser Fiber MF 600BH 2016-09-24
B324MF600BHC0MaxiFlex Holmium Laser Fiber MF 600BH C2016-09-24
B324MF600BHD0MaxiFlex Holmium Laser Fiber MF 600BH D2016-09-24
B324MF600BHN0MaxiFlex Holmium Laser Fiber MF 600BH N2016-09-24
B324MF600BHT0MaxiFlex Holmium Laser Fiber MF 600BH T2016-09-24
B324MF1000BHCR0MaxiFlex Holmium Laser Fiber MF 1000BH C R2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390458Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07