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Laser Engineering

Primary DI
00860011139706
Brand
Laser Engineering
Company
LASER ENGINEERING
Model
OTO Handpiece
Catalog number
1059746
Device description
Re-usable fiberoptic handpiece for lasers
Published
2024-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00860011139706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011139706008600111397068600111397060860011139706

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5085202552r.rudko@laserengineering.com

Regulatory Flags#

DUNS number
028541358
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866988000292Laser EngineeringHWG305-OTOHWG305-OTO2024-08-20
00866988000285Laser EngineeringHWG305HWG3052024-08-20
10866988000299Laser EngineeringHWG305-OTOHWG305-OTO2024-08-20
00866988000216UltraLase Flexible Laser WaveguideHWG505HWG5052021-11-08
10866988000213UltraLase Flexible Laser WaveguideHWG505HWG5052021-11-08
00866988000230ImperiumCO2-500CO2-5002018-12-31
00866988000261UltraLase Flexible Laser WaveguideHWG300-OTOHWG300-OTO2020-03-23
00866988000209UltraLase Flexible Laser WaveguideHWG500-2.0-3.0HWG500-2.0-3.02016-09-20
00866988000223UltraLase Flexible Laser WaveguideHWG300-2.0-3.0HWG300-2.0-3.02016-09-20
00866988000247ImperiumCO2-300CO2-3002018-12-31
10866988000268UltraLase Flexible Laser WaveguideHWG300-OTOHWG300-OTO2020-03-23
10866988000237ImperiumCO2-500CO2-5002018-12-31

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Primary DI, Brand, Company table
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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
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