FDA.reportPublic FDA data

SOLAR STORM 48ST

Primary DI
G710SS48ST0
Brand
SOLAR STORM 48ST
Company
SUNSHINE USA, LLC
Model
SS48ST
Catalog number
SS48ST
Device description
The 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
2025-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LEJBooth, Sun Tan

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180576000Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)Lpi, Inc.2018-04-19LEJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G710SS48ST0PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
104258633
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G710L240Velara Lounge 24L24L242026-05-15
G710A480Velara Ascend 48A48A482026-05-11
G710E320Velara Elite 32E32E322026-05-11
G71032C0SOLAR STORM 32CSS32CSS32C2025-08-14
G710AV160AVALON 16AV16AV162025-08-14
G710AV200AVALON 20AV20AV202025-08-14
G710AV240AVALON 24AV24AV242025-08-14
G710AV280AVALON 28AV28AV282025-08-14
G710AV32AVALON 32AV32AV322025-08-14
G710GAL160GALAXY 16GA16GA162025-08-14
G710GAL180GALAXY 18GA18GA182025-08-14
G710GAL220GALAXY 22GA22GA222025-08-14
G710GAL240GALAXY 24GA24GA242025-08-14
G710GAL300GALAXY 30GA30GA302025-08-14
G710OA360OASIS 36OA36OA362025-08-14
G710SF32X0SUNFIRE 32X PLATINUMSF32XSF32X2025-08-14
G710SS300SOLAR STORM 30SS30SS302025-08-14
G710SS32R0SOLAR STORM 32RSS32RSS32R2025-08-14
G710SS32S0SOLAR STORM 32SSS32SSS32S2025-08-14
G710SS36ST0SOLAR STORM 36STSS36STSS36ST2025-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G1503210REJUVENESSENCELight Sources, Inc.LEJ2026-07-20
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
08600124614316Ultrasun Q10-3 Magnum PowerUltrasun 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
G1502L0023SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3100SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3101SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3160SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3185SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3810SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3818SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3822SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3825SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L4125DR.MÜLLERLight Sources, Inc.LEJ2026-06-26
G1502L4180DR.MÜLLERLight Sources, Inc.LEJ2026-06-26
G1502L6200DR.MÜLLERLight Sources, Inc.LEJ2026-06-26
G1502L6216DR.MÜLLERLight Sources, Inc.LEJ2026-06-26
G1502L6220DR.MÜLLERLight Sources, Inc.LEJ2026-06-26
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