FDA.reportPublic FDA data

NeuLight®

Primary DI
02816901023318
Brand
NeuLight®
Company
Weinert Fiber Optics, Inc.
Model
WFS-600-SB
Catalog number
095632
Published
2026-03-12
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01816901023319PackageGS15Not in Commercial Distribution
02816901023318PackageGS12Not in Commercial Distribution
00816901023310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01816901023319018169010233191816901023319
02816901023318028169010233182816901023318
00816901023310008169010233108169010233100816901023310

GMDN Terms#

Term, Definition table
TermDefinition
Urogenital surgical laser system beam guide, single-useA 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, ureteral conditions (e.g., tumours, condylomas) or gynaecological disorders; 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
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
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
00816901022573Typenex MedicalNV06330975102021-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976712970297Hemolase FiberMicro-Energy Medical Technology Co., LtdGEX2026-07-13
06976712970303Hemolase FiberMicro-Energy Medical Technology Co., LtdGEX2026-07-13
06976712970310Hemolase FiberMicro-Energy Medical Technology Co., LtdGEX2026-07-13
06976712970327Hemolase FiberMicro-Energy Medical Technology Co., LtdGEX2026-07-13
08800291820200DermaVCynosure Lutronic Technology CorporationGEX2026-06-23
08800291820040CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820057CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820187CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820460HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820477HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820484HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820859PICOPLUSCynosure Lutronic Technology CorporationGEX2026-06-22
06973511890177SANOBeijing Sano Lasers S&T Development Co., Ltd.GEX2026-06-10
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
B17731260532L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2025-07-23
B17731260532Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2025-07-23
B17731260455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2025-07-21
B17731260455Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2025-07-21
00647529004722Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
00647529004777Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31