FDA.reportPublic FDA data

Solar Wave 16

Primary DI
G710SW1603
Brand
Solar Wave 16
Company
SUNSHINE USA, LLC
Model
SW16
Catalog number
SW16
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 the tanning the human skin of an adult person.
Published
2025-06-25
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
LEJBooth, Sun Tan

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152423000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152423000Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning CanopySunfire Industries, Inc.2016-05-20LEJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G710SW1603PackageHIBCC1In Commercial Distribution
G710SW160PrimaryHIBCC0

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
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
false
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
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
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
G5103178RENUVATANLight Sources, Inc.LEJ2026-04-22