FDA.reportPublic FDA data

neoLaser Laser Surgery Fiber

Primary DI
07290020432193
Brand
neoLaser Laser Surgery Fiber
Company
G.N.S NEOLASER LTD
Model
OF90040
Catalog number
OF90040
Device description
neoLaser Laser Surgery Fiber 2.5 NC 600 XSCV 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
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
07290020432193PackageGS15In Commercial Distribution
07290020432209PackageGS110In Commercial Distribution
07290020432186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290020432193072900204321937290020432193
07290020432209072900204322097290020432209
07290020432186072900204321867290020432186

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600476878
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
false
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
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
07290020432063neoLaser Laser Surgery Fiber OF90025OF900252025-05-20
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
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
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
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390458Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
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