FDA.reportPublic FDA data

DUO+ 180 (LS-B 2250)

Primary DI
B271DUO1800
Brand
DUO+ 180 (LS-B 2250)
Company
Meditech International Inc
Model
LS-B 2250
Published
2016-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023621000
K051875000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023621000BIOFLEX PROFESSIONAL THERAPY SYSTEMMeditech International, Inc.2003-04-10ILY
K051875000BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADSMeditech International, Inc.2006-03-13ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B271DUO1800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, line-poweredA mains electricity (AC-powered) device designed to emit a low-level narrow-band (LLNB) red light in the visible and invisible wavelength around 600-940 nm, with the intent to modify cellular metabolism and/or improve blood flow through increased vasodilation primarily for the accelerated healing of cutaneous or mucosal wounds and/or to provide pain relief. It can be used in a healthcare facility and in the home. It may be used to help treat skin ulcers, acne, herpes simplex lesions, and postoperative wounds, or to relieve pain associated with inflammatory processes such as rheumatoid arthritis (RA) or lower back injury.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
255079485
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B271MCUI0MiniPort Main Controller UnitMCU I2023-10-02
B271MCUIH0Main Controller Unit I Home (MCU I-H)MCU I-H2025-06-26
B271MCUIP0Main Controller Unit I Professional (MCU I-P)MCU I-P2025-06-26
B271ART1800SLD+ 180ASLD+ 180A2023-09-18
B271CUPA0Controller Unit (CU+A)CU+A2023-09-18
B271CU0Controller Unit (CU)CU2016-08-09
B271CUP0Controller Unit (CU+)CU+2016-08-09
B271DUO2400DUO+ 240 (LS-B 3000)LS-B 30002016-08-09
B271LDI200P0LD-I 200+LD-I 200+2018-02-01
B271LDR100P0LD-R 100+LD-R 100+2018-02-01
B271LSB2250P0DUO+ 180 (LS-B 2250+)LS-B 2250+2018-02-01
B271LSB3000P0DUO+ 240 (LS-B 3000+)LS-B 3000+2018-02-01
B271LSB32700DUOFLEX+ 120 (LS-B 3270)LS-B 32702018-02-01
B271LSB48900DUOFLEX+ 180 (LS-B 4890)LS-B 48902018-02-01
B271MCU0Main Controller Unit (MCU)MCU2016-08-09
B271MCUIII0Main Controller Unit III (MCU III)MCU III2018-02-01
B271MCUIV0Main Controller Unit IV (MCU IV)MCU IV2018-02-01
B271LDI2000LD-I 200LD-I 2002016-08-09
B271LDR1000LD-R 100LD-R 1002016-08-09
B271SLD1200SLD+ 120SLD+ 1202016-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00850087184007HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688989HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688996HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
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08800020111852HILTHERAJeisys Medical Inc.ILY2026-07-21
00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
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B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
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G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
00810140063014RENPHOJoicom CorporationILY2026-05-08