FDA.reportPublic FDA data

neoLaser Laser Surgery Fiber

Primary DI
07290020432063
Brand
neoLaser Laser Surgery Fiber
Company
G.N.S NEOLASER LTD
Model
OF90025
Catalog number
OF90025
Device description
neoLaser Laser Surgery Fiber 2.5 NC 600 CSCH 1.8
Published
2025-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
07290020432070PackageGS15In Commercial Distribution
07290020432087PackageGS110In Commercial Distribution
07290020432063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290020432070072900204320707290020432070
07290020432087072900204320877290020432087
07290020432063072900204320637290020432063

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, single-useA 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; a fibreoptic cable may be included with the device. This is a single-use device.

Regulatory Flags#

DUNS number
600476878
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290020432247neoLaser Laser Surgery Fiber OF90046OF900462025-10-01
07290020432278neoLaser Laser Surgery Fiber OF90047OF900472025-10-01
07290020432339neoLaser Laser Surgery Fiber OF90041OF900412025-10-01
07290020432001neoLaser Laser Surgery Fiber OF90019OF900192025-05-20
07290020432032neoLaser Laser Surgery Fiber OF90024OF900242025-05-20
07290020432094neoLaser Laser Surgery Fiber OF90028OF900282025-05-20
07290020432124neoLaser Laser Surgery Fiber OF90043OF900432025-05-20
07290020432155neoLaser Laser Surgery Fiber OF90044OF900442025-05-20
07290020432186neoLaser Laser Surgery Fiber OF90040OF900402025-05-20
07290020432216neoLaser Laser Surgery Fiber OF90042OF900422025-05-20
07290020432018neoLaser Laser Surgery Fiber OF90019OF900192025-05-20
07290020432049neoLaser Laser Surgery Fiber OF90024OF900242025-05-20
07290020432070neoLaser Laser Surgery Fiber OF90025OF900252025-05-20
07290020432100neoLaser Laser Surgery Fiber OF90028OF900282025-05-20
07290020432131neoLaser Laser Surgery Fiber OF90043OF900432025-05-20
07290020432162neoLaser Laser Surgery Fiber OF90044OF900442025-05-20
07290020432193neoLaser Laser Surgery Fiber OF90040OF900402025-05-20
07290020432223neoLaser Laser Surgery Fiber OF90042OF900422025-05-20
07290016629002neoVneoV980BG980002016-09-01
07290016629033neoVneoV980BG980032016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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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
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08052049500326Splendor XBIOS SRLGEX2025-01-16
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08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00850064466027FREDDOFABINJECT LLCGEX2024-10-28
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
00860007603761Sentient ManufacturingSentient Manufacturing, LLCGEX2022-09-16
00860007603747Sentient ManufacturingSentient Manufacturing, LLCGEX2022-09-16