FDA.reportPublic FDA data

FiberTech®

Primary DI
04059497000303
Brand
FiberTech®
Company
LEONI Fiber Optics GmbH
Model
FT IR200/240ST-3/SL-F 1500K3L
Catalog number
M220150S
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
false

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
04059497000303PackageGS15In Commercial Distribution
04059497000549PackageGS12In Commercial Distribution
04059497000068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059497000303040594970003034059497000303
04059497000549040594970005494059497000549
04059497000068040594970000684059497000068

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a reusable device intended to be sterilized prior to use.

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
008164690216981150-500LASER PERIPHERALS, LLCGEX2026-06-08
G866ELITELT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
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
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
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
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390090Twain EvoQUANTA SYSTEM SPAGEX2018-12-14