FDA.reportPublic FDA data

neoLaser Laser Surgery Fiber

Primary DI
07290020432070
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
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
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.

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
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
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
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16