FDA.reportPublic FDA data

Imperium

Primary DI
00866988000247
Brand
Imperium
Company
LASER ENGINEERING
Model
CO2-300
Catalog number
CO2-300
Device description
CO2 Laser Waveguide - 300 microns
Published
2018-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112166000ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDEW and R Investments Dba Laser Engineering2011-10-21GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10866988000244PackageGS13In Commercial Distribution
00866988000247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086698800024410866988000244
00866988000247008669880002478669880002470866988000247

GMDN Terms#

Term, Definition table
TermDefinition
Urogenital surgical laser system beam guide, single-useA sterile, flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, and ureteral conditions (e.g., tumours, condylomas); it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(508) 520-2500customerinfo@laserengineering.com

Regulatory Flags#

DUNS number
028541358
Device count
1
Lot or batch
true
Expiration date on label
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
00860011139706Laser EngineeringOTO Handpiece10597462024-04-11
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
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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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
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G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
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
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00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
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