DEVICE: AVALON 24 (G710AV240)

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Device Record History
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Device Identifier (DI) Information
AVALON 24
AV24
In Commercial Distribution
AV24
SUNSHINE USA, LLC
G710AV240
HIBCC

1
104258633 *Terms of Use
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.
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
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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
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FDA Product Code

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Product Code Product Code Name
LEJ Booth, Sun Tan
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K180576 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
ba80c441-8647-4b85-8fa1-02d16e3a838f
August 22, 2025
1
August 14, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
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Customer Contact

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No Customer Contact currently defined
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