FDA.reportPublic FDA data

NA

Primary DI
16974958310157
Brand
NA
Company
Shenzhen Idea Light Limited
Model
TLB300V
Device description
LED Red Therapy Light
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974958310157PackageGS110In Commercial Distribution
06974958310150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697495831015716974958310157
06974958310150069749583101506974958310150

GMDN Terms#

Term, Definition table
TermDefinition
Red/infrared light phototherapy unitAn electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
403696005
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974958310457LIFEPRO FITNESSLP-RJVGRW-BLK2026-04-17
06974958310549ideatherapyTLM2002026-04-17
06974958310556LIFEPRO FITNESSLP-RVTGLW-WHT2026-04-17
06974958310563LIFEPRO FITNESSLP-RVTGLWP-WHT2026-04-17
06974958310044ideainfraredRTL12C2024-08-16
06974958310082ideainfraredRL60S2024-08-16
06974958310136IdeainfraredTLB1052023-07-27
06974958310143IdeainfraredTLB1202023-07-27
06974958310150 IdeainfraredTLB3002023-07-27
06974958310167NARL05C2023-07-27
16974958310133NATLB105V2023-07-27
16974958310140NATLB120V2023-07-27
16974958310164NARL05C2023-07-27

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Primary DI, Brand, Company table
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00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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