FDA.reportPublic FDA data

neoLaser Laser Surgery Fiber

Primary DI
07290020432032
Brand
neoLaser Laser Surgery Fiber
Company
G.N.S NEOLASER LTD
Model
OF90024
Catalog number
OF90024
Device description
neoLaser Laser Surgery Fiber 2.5 NC 400 RSCV 1.3
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
07290020432049PackageGS15In Commercial Distribution
07290020432056PackageGS110In Commercial Distribution
07290020432032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290020432049072900204320497290020432049
07290020432056072900204320567290020432056
07290020432032072900204320327290020432032

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
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
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
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
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16