FDA.reportPublic FDA data

Joovv Solo 3.0

Primary DI
10855501008263
Brand
Joovv Solo 3.0
Company
JOOVV, INC.
Model
PT500-F0486
Device description
The Joovv Solo 3.0 is a portable phototherapy device that emits light in the Red and Near Infrared spectrum.
Published
2021-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855501008263PackageGS12In Commercial Distribution
00855501008266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085550100826310855501008263
00855501008266008555010082668555010082660855501008266

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-465-6688help@joovv.com

Regulatory Flags#

DUNS number
104893063
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
00855501008617Joovv CloudPT500-F00462025-11-18
00855501008013Joovv SoloEA-1506608502019-11-12
00855501008228Joovv Go NIREA-0128500002019-11-12
00855501008006Joovv MiniEA-0606608502019-11-12
00855501008266Joovv Solo 3.0PT500-F04862021-07-01
00855501008273Joovv Mini 3.0PT500-F04872021-07-01
00855501008280Joovv Go 2.0PT500-F04882021-07-01
00855501008211Joovv Go RedEA-0126600002019-11-12
10855501008218Joovv Go RedEA-0126600002019-11-12
10855501008225Joovv Go NIREA-0128500002019-11-12
10855501008010Joovv SoloEA-1506608502019-11-12

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Primary DI, Brand, Company table
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