FDA.reportPublic FDA data

NorLab

Primary DI
00860009621923
Brand
NorLab
Company
Norco, Inc.
Model
Medical Laser Gas
Device description
Gases used as a medium for various medical lasers.
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K904162000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904162000CARBON DIOXIDE FLOWTHROUGH LASER MIXTURESNorco, Inc.1990-10-19GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009621923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009621923008600096219238600096219230860009621923

GMDN Terms#

Term, Definition table
TermDefinition
Laser-generating gasA gaseous mixture intended to be used as a lasing medium (to produce a laser beam) typically for use in dermatological or general and plastic surgery procedures.

Regulatory Flags#

DUNS number
043694645
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009621909NorLabMedical Calibration Gas2022-12-12
00860009621916NorLabMedical Blood Gas2022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800291820200DermaVCynosure Lutronic Technology CorporationGEX2026-06-23
08800291820040CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820057CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820187CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820460HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
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
G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
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
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
00647529004722Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
00647529004777Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00850064466027FREDDOFABINJECT LLCGEX2024-10-28
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
00860007603761Sentient ManufacturingSentient Manufacturing, LLCGEX2022-09-16
00860007603747Sentient ManufacturingSentient Manufacturing, LLCGEX2022-09-16