FDA.reportPublic FDA data

SLD+ 180A

Primary DI
B271ART1800
Brand
SLD+ 180A
Company
Meditech International Inc
Model
SLD+ 180A
Published
2023-09-18
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
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
B271ART1800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, professionalAn electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood circulation. It is a non-wearable device which may be in the form of a hand-held, freestanding or mounted unit, and is intended to be used by a healthcare professional in a clinical setting.

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
B271CUPA0Controller Unit (CU+A)CU+A2023-09-18
B271CU0Controller Unit (CU)CU2016-08-09
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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