FDA.reportPublic FDA data

Ultrasun Q10-3 Magnum Power

Primary DI
08600124614316
Brand
Ultrasun Q10-3 Magnum Power
Company
Ultrasun International B.V.
Model
1V31D314BC862
Device description
Device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning the human skin of an adult person.
Published
2026-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LEJBooth, Sun Tan

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEJBooth, Sun TanGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08600124614316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08600124614316086001246143168600124614316

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet tanning deviceA mains electricity (AC-powered) lamp or bed/booth with lamps designed to provide radiation in the ultraviolet spectrum for tanning the skin. This device is used for cosmetic purposes.

Regulatory Flags#

DUNS number
403421761
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
08600124614163Ultrasun E61V16D304AC8422026-07-03
08600124614262Ultrasun Q6-01V26D304AC8422026-07-03
08600124614279Ultrasun Q6-2 Magnum Power1V27D304BC8422026-07-03
08600124614309Ultrasun Q10-01V30D314AC4432026-07-03
08600124614378Ultrasun Q16-31V37C314BC9622026-07-03
08600124614392Ultrasun Q18-4x500 MP1V39D320NC8622026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08600124614163Ultrasun E6Ultrasun International B.V.LEJ2026-07-03
08600124614262Ultrasun Q6-0Ultrasun International B.V.LEJ2026-07-03
08600124614279Ultrasun Q6-2 Magnum PowerUltrasun International B.V.LEJ2026-07-03
08600124614309Ultrasun Q10-0Ultrasun International B.V.LEJ2026-07-03
08600124614378Ultrasun Q16-3Ultrasun International B.V.LEJ2026-07-03
08600124614392Ultrasun Q18-4x500 MPUltrasun International B.V.LEJ2026-07-03
G5102226NEW TECHNOLOGYLight Sources, Inc.LEJ2026-05-19
G51017010RENUVATANLight Sources, Inc.LEJ2026-05-12
G5101908RENUVATANLight Sources, Inc.LEJ2026-05-12
G5103370RENUVATANLight Sources, Inc.LEJ2026-05-12
G5100821RENUVATANLight Sources, Inc.LEJ2026-05-04
G5100760RENUVATANLight Sources, Inc.LEJ2026-04-29
G5103222RENUVATANLight Sources, Inc.LEJ2026-04-29
G5103137RENUVATANLight Sources, Inc.LEJ2026-04-27
G5103178RENUVATANLight Sources, Inc.LEJ2026-04-22
G1502386VIP PREMIERLight Sources, Inc.LEJ2026-04-20
G1503372GENESISLight Sources, Inc.LEJ2026-04-13
G5101318RENUVATANLight Sources, Inc.LEJ2026-04-10
G5101586RENUVATANLight Sources, Inc.LEJ2026-04-10
G5101915RENUVATANLight Sources, Inc.LEJ2026-04-10
G5102274RENUVATANLight Sources, Inc.LEJ2026-04-10
G5102701RENUVATANLight Sources, Inc.LEJ2026-04-10
G5103119RENUVATANLight Sources, Inc.LEJ2026-04-10
G5103244RENUVATANLight Sources, Inc.LEJ2026-04-10
G5103269RENUVATANLight Sources, Inc.LEJ2026-04-10
G5101180RENUVATANLight Sources, Inc.LEJ2026-04-02
G5101450RENUVATANLight Sources, Inc.LEJ2026-04-02
G5102700RENUVATANLight Sources, Inc.LEJ2026-04-02
G5103133RENUVATANLight Sources, Inc.LEJ2026-04-02
G5103356RENUVATANLight Sources, Inc.LEJ2026-04-02