FDA.reportPublic FDA data

NA

Primary DI
02816901022212
Brand
NA
Company
LEONI FIBER OPTICS, INC.
Model
LFR-800-SB
Catalog number
095455
Published
2019-10-01
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
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
01816901022213PackageGS15In Commercial Distribution
02816901022212PackageGS12In Commercial Distribution
00816901022214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01816901022213018169010222131816901022213
02816901022212028169010222122816901022212
00816901022214008169010222148169010222140816901022214

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039281260
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
01816901023401NeuLight®WFS-272-SB0954482023-03-17
01816901023425NeuLight®LFS-365-SB0954492023-03-17
01816901023418NeuLight®LFS-200-SB0951932023-02-12
01816901023470Typenex MedicalNV06330975102023-02-03
01816901023708Typenex MedicalNV06350975122023-02-03
01816901023746NeuLight®WFR-200-SB0951972022-11-04
01816901023753NeuLight®WFR-550-SB0951992022-11-04
02816901023769NeuLight®WFR-940-SB0952022022-11-04
02816901023776NeuLight®WFR-365-SB0954542022-11-04
01816901023784NeuLight®WFS-600-SF0989002022-11-04
01816901023791NeuLight®WFR-940-SB0988992022-11-04
02816901023806Acquire MedQ-272-RT0966552022-11-05
01816901023814Acquire MedQ-550-RT0967902022-11-05
01816901023326NeuLight®WFS-6000983302022-10-31
01816901022329LEONI™LFS-200-SB0988842022-02-21
01816901022978LEONI™LFR-200-SB0988852022-02-21
01816901023111LEONI™LFR-940-SB0990692022-02-21
02816901023127LEONI™LFS-940-SB0990682022-02-21
01816901023104LEONI™LFR-550-SB0990222021-11-19
01816901023050EndoMasterLFS-272-SB0989632021-07-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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