FDA.reportPublic FDA data

FiberTech®

Primary DI
04059497000280
Brand
FiberTech®
Company
LEONI Fiber Optics GmbH
Model
FT IR365/400ST-3/SL-F 120011L
Catalog number
M210300S
Published
2016-09-29
Public version status
Update
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
GEXPowered laser surgical instrument

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050738000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050738000FT FIBER OPTIC DELIVERY SYSTEMSFibertech GmbH2005-06-02GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059497000280PackageGS15In Commercial Distribution
04059497000525PackageGS12In Commercial Distribution
04059497000044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059497000280040594970002804059497000280
04059497000525040594970005254059497000525
04059497000044040594970000444059497000044

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342703174
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059497000037CoolLipoTMCL 320 SM210273S2016-09-29
04059497000723CoolLipoTMCL 500 SM210608S2016-09-29
04059497000068FiberTech®FT IR200/240ST-3/SL-F 1500K3LM220150S2016-09-29
04059497000075FiberTech®FT IR272/300ST-3/SL-F 1500K3LM220200S2016-09-29
04059497000082FiberTech®FT IR365/400ST-3/SL-F 1500K3LM220300S2016-09-29
04059497000099FiberTech®FT IR550/605ST-3/SL-F 1500K3LM220500S2016-09-29
04059497000105CoolLipoTMCL 500 RM220522N2016-09-29
04059497000112CoolLipoTMCL 320 RM220921N2016-09-29
04059497000006FiberTech®FT IR600/720HCN-3/SF-2050 003001CM102962S2016-09-29
04059497000198FiberTech®FT IR600/720HCN-3/SL-SF-1750 003711CM280202S2016-09-29
04059497000204FiberTech®FT IR600/720HCN-3/SL-SF-2050 L12011FM280311S2016-09-29
04059497000211FiberTech®FT IR600/720HCN-3/SL-SF-2050 L12011FM280317S2016-09-29
04059497000488FiberTech®FT IR600/720HCN-3/SL-SF-2050 0S2011FM280317S2017-08-08
04260438610028FiberTech®FT IR600/720HCN-3/SL-SF-2000 012011LM280300S2016-09-29
04059497000013FiberTech®FT IR200/240ST-3/SL-F 120011LM210150S2016-09-29
04059497000020FiberTech®FT IR273/300ST-3/SL-F 120011LM210200S2016-09-29
04059497000044FiberTech®FT IR365/400ST-3/SL-F 120011LM210300S2016-09-29
04059497000051FiberTech®FT IR550/605ST-3/SL-F 120011LM210500S2016-09-29
04059497000129FiberTech®FT IR210/220A-2.5/SM-ES23 000311LM270200S2016-09-29
04059497000136FiberTech®FT IR200/220PI-2.5/SMI-ES23 5K0CK1FM270202S2016-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16