DEVICE: SOLAR STORM 24C (G710SS24C0)
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Device Identifier (DI) Information
SOLAR STORM 24C
SS 24C
In Commercial Distribution
SS24C
SUNSHINE USA, LLC
SS 24C
In Commercial Distribution
SS24C
SUNSHINE USA, LLC
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.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 46387 | Ultraviolet tanning device |
A 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LEJ | Booth, Sun Tan |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K180576 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
bdf02fe9-170a-4544-8797-3bb086d86a78
August 21, 2025
1
August 13, 2025
August 21, 2025
1
August 13, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined