Velara Lounge 24 - This is a Class II infrared therapeutic heating lamp (Product Code ILY, 21 CFR 890.5500) intended for localized heat therapy to relieve muscle pain, joint stiffness, and improve local blood circulation.
2026-05-15
Sunshine USA, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009973354 | 3009973354 | Sunshine USA, LLC | 1 | N | 2026-01-01 | 2225 Eddie Williams Rd JC TN US 37601 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 149812 | 1372925201 | K180576 | Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) | LEJ | 2018-04-19 |
| 149812 | 2011265668 | K152423 | Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy | LEJ | 2016-05-20 |
| 149812 | 1891577784 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LEJ | 4 | 2018-04-19 |
GUDID#
Velara Ascend 48 - This is a Class II infrared therapeutic heating lamp (Product Code ILY, 21 CFR 890.5500) intended for localized heat therapy to relieve muscle pain, joint stiffness, and improve local blood circulation.
2026-05-11
Velara Elite 32 - This is a Class II infrared therapeutic heating lamp (Product Code ILY, 21 CFR 890.5500) intended for localized heat therapy to relieve muscle pain, joint stiffness, and improve local blood circulation.
2026-05-11
SOLAR STORM 32C - 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.
2025-08-14
AVALON 16 - 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.
2025-08-14
AVALON 20 - 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.
2025-08-14
AVALON 24 - 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.
2025-08-14
AVALON 28 - 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.
2025-08-14
AVALON 32 - 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.
2025-08-14
GALAXY 16 - 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.
2025-08-14
GALAXY 18 - 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.
2025-08-14
GALAXY 22 - 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.
2025-08-14
GALAXY 24 - 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.
2025-08-14
GALAXY 30 - 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.
2025-08-14
OASIS 36 - 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.
2025-08-14
SUNFIRE 32X PLATINUM - 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.
2025-08-14
SOLAR STORM 30 - 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.
2025-08-14
SOLAR STORM 32R - 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.
2025-08-14
SOLAR STORM 32S - 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.
2025-08-14
SOLAR STORM 36ST - 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.
2025-08-14
SOLAR STORM 48ST - 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.
2025-08-14
SOLAR STORM 24C - THE DEVICE IS AN OVER-THE-COUNTER TANNING DEVICE EMITTING ULTRAVIOLET LIGHT IN HTE UVB AND UVA REGION OF THE SPECTRUM INTENDED FOR TANNING THE HUMAN SKIN OF AN ADULT PERSON.
2025-08-13
SOLAR STORM 24R - THE DEVICE IS AN OVER-THE-COUNTER TANNING DEVICE EMITTING ULTRAVIOLET LIGHT IN HTE UVB AND UVA REGION OF THE SPECTRUM INTENDED FOR TANNING THE HUMAN SKIN OF AN ADULT PERSON.
2025-08-13
SOLAR STORM 24S - THE DEVICE IS AN OVER-THE-COUNTER TANNING DEVICE EMITTING ULTRAVIOLET LIGHT IN HTE UVB AND UVA REGION OF THE SPECTRUM INTENDED FOR TANNING THE HUMAN SKIN OF AN ADULT PERSON.
2025-08-13
Solar Wave 24 - THE DEVICE IS AN OVER-THE-COUNTER TANNING DEVICE EMITTING ULTRAVIOLET LIGHT IN HTE UVB AND UVA REGION OF THE SPECTRUM INTENDED FOR TANNING THE HUMAN SKIN OF AN ADULT PERSON.
2025-08-13
Solar Wave 24 220V - THE DEVICE IS AN OVER-THE-COUNTER TANNING DEVICE EMITTING ULTRAVIOLET LIGHT IN HTE UVB AND UVA REGION OF THE SPECTRUM INTENDED FOR TANNING THE HUMAN SKIN OF AN ADULT PERSON.
2025-08-13
Solar Wave 16 - 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.
2025-06-25
Solar Wave 16 - 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.
2025-06-25