FDA.reportPublic FDA data

Shenzhen Wells Optoelectronics Co.,Ltd.

Primary DI
06977182812018
Brand
Shenzhen Wells Optoelectronics Co.,Ltd.
Company
Shenzhen Wells Optoelectronics Co.,Ltd.
Model
IR201
Device description
Red light beauty telt/IR201
Published
2024-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06977182812018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977182812018069771828120186977182812018

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
549645451
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977182810113Shenzhen Wells Optoelectronics Co.,Ltd.DZ012024-06-16
06977182819192Shenzhen Wells Optoelectronics Co.,Ltd.919AS2024-06-16
06977182819390Shenzhen Wells Optoelectronics Co.,Ltd.9392024-06-16
16977182810073Shenzhen Wells Optoelectronics Co.,Ltd.CD07S2024-06-16
06977182810014Shenzhen Wells Optoelectronics Co.,Ltd.DZ-012024-06-11

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