FDA.reportPublic FDA data

Controller Unit (CU)

Primary DI
B271CU0
Brand
Controller Unit (CU)
Company
Meditech International Inc
Model
CU
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
NHNPowered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain TherapyPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051875000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051875000BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADSMeditech International, Inc.2006-03-13ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B271CU0PrimaryHIBCC0

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
Premarket exempt
true
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
B271CUP0Controller Unit (CU+)CU+2016-08-09
B271DUO1800DUO+ 180 (LS-B 2250)LS-B 22502016-08-09
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

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