FDA.reportPublic FDA data

NeuLight®

Primary DI
00816901024058
Brand
NeuLight®
Company
Weinert Fiber Optics, Inc.
Model
WFR-200-SB
Catalog number
099071
Published
2024-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01816901024057PackageGS15In Commercial Distribution
02816901024056PackageGS12In Commercial Distribution
00816901024058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01816901024057018169010240571816901024057
02816901024056028169010240562816901024056
00816901024058008169010240588169010240580816901024058

GMDN Terms#

Term, Definition table
TermDefinition
Urogenital surgical laser system beam guide, reusableA flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications [e.g., to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), to treat bladder, urethral, and ureteral conditions (e.g., tumours, condylomas), to heat/ablate mucosal tissue to treat vaginal laxity]. It is designed to direct laser light from a laser generator to the surgical site and may be available in a variety of configurations/technologies (using, e.g., fibreoptic materials, specialized mirrors). This is a reusable device intended to be sterilized prior to use.

Regulatory Flags#

DUNS number
039281260
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816901024171NeuLight®WFS-365-SB0988892026-04-27
00816901023310NeuLight®WFS-600-SB0956322026-03-12
00816901024034NeuLight®WF IR600HCT 3/SM-F 2M20Z1C0994712026-03-12
00816901024157NeuLight®WF IR600T-3/SM-F 1L30Z1S0956322026-03-12
02816901023318NeuLight®WFS-600-SB0956322026-03-12
02816901024032NeuLight®WF IR600HCT 3/SM-F 2M20Z1C0994712026-03-12
01816901024156NeuLight®WF IR600T-3/SM-F 1L30Z1S0956322026-03-12
00816901020418NANV06140974282016-10-05
00816901020449NANV06320975092016-10-05
00816901020456NANV06330975102016-10-05
00816901020463NANV06340975112016-10-05
00816901020470NANV06350975122016-10-05
00816901020487NANV06260975252016-10-05
00816901020494NANV06150975262016-10-05
00816901020500NANV06270975272016-10-05
00816901021071NAVNP FIBRUSE-BT0970262016-10-11
00816901021750NANV06150983092019-03-01
00816901022542Typenex MedicalNV06150983092021-06-24
00816901022559Typenex MedicalNV06350975122021-06-05
00816901022566Typenex MedicalNV06340975112021-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B17700100852TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
B17700100853TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
06970453310015MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310084MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310114MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06971679500105LED Therapy DeviceBeijing Nubway S&T Co., Ltd.GEX2026-09-24
06970745912927ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912934ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912996ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
04053002150316Bare Fiber 400 T Luer LockLight Guide Optics International SIAGEX2026-08-14
04053002150415Bare Fiber 600 T Luer LockLight Guide Optics International SIAGEX2026-08-14
04053002150514CORONA 360 Fused 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
04053002150613CORONA Infinite Ring XSCF 600 1.6 USLight Guide Optics International SIAGEX2026-08-14
04053002150712Rigid Infinite Ring HSC Probe 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
06973011720080CO2 Laser Therapy SystemSanhe LEFIS Electronics Co., LtdGEX2026-08-07
06973011720103Q Switched Nd: YAG Laser machineSanhe LEFIS Electronics Co., LtdGEX2026-08-07
00872320007195Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.GEX2026-08-03
06976812430271Medical Thulium Fiber Laser SystemsRhein Laser Technologies Co.,Ltd.GEX2026-07-30
08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
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