FDA.reportPublic FDA data

OMNILUX

Primary DI
B434EM1258S0
Brand
OMNILUX
Company
LOTUS GLOBAL GROUP, INC, THE
Model
EM1258S
Device description
OMNILUX MEDICAL BASE
Published
2016-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030426000
K030883000
K043317000
K043329000
K050216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030426000OMNILUX REDPhoto Therapeutics Limited2003-07-17GEX
K030883000OMNILUX BLUEPhoto Therapeutics Limited2003-06-18GEX
K043317000OMNILUX PLUSPhoto Therapeutics Limited2005-03-15ILY
K043329000OMNILUX REVIVE AND BLUEPhoto Therapeutics Limited2005-03-18GEX
K050216000OMNILUX REVIVE AND OMNILUX PLUSPhoto Therapeutics Limited2005-08-09GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B434EM1258S0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, professionalAn electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for internal (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated by a healthcare professional exclusively in a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
969797406
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B434EM1310OMNILUXEM13102016-12-05
B434EM1387OMNILUXEM13872016-12-05
B434EM1654OMNILUXEM16542016-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B17700100852TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
B17700100853TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
00850012528630ILYEO bodyJoylux, Inc.ILY2026-09-29
00850061407221LS Pro SystemsWELLNESS WITHOUT LIMITS LLCILY2026-09-24
06970453310015MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310084MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310114MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06971679500105LED Therapy DeviceBeijing Nubway S&T Co., Ltd.GEX2026-09-24
06974958310594mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310600mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310617mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310624mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06979994630002CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630019CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630026CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630033CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630040CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
08800190200004OLIZLTBIO Co., Ltd.ILY2026-08-26
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
B5171301410Energy Flo TDP Heat LampAcu MarketILY2026-08-21
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
09361725025374BON CHARGELight Tree Ventures Europe B.V.ILY2026-08-11