GALAXY 16 GA16

GUDID G710GAL160

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.

SUNSHINE USA, LLC

Ultraviolet tanning device
Primary Device IDG710GAL160
NIH Device Record Key865da7f2-363c-4b69-9dba-23a0d4d00633
Commercial Distribution StatusIn Commercial Distribution
Brand NameGALAXY 16
Version Model NumberGA16
Catalog NumberGA16
Company DUNS104258633
Company NameSUNSHINE USA, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG710GAL160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LEJBooth, Sun Tan

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-22
Device Publish Date2025-08-14

Devices Manufactured by SUNSHINE USA, LLC

G71032C0 - SOLAR STORM 32C2025-08-22 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
G710AV160 - AVALON 162025-08-22 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
G710AV200 - AVALON 202025-08-22 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
G710AV240 - AVALON 242025-08-22 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
G710AV280 - AVALON 282025-08-22 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
G710AV32 - AVALON 322025-08-22 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
G710GAL160 - GALAXY 162025-08-22The 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.
G710GAL160 - GALAXY 162025-08-22 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
G710GAL180 - GALAXY 182025-08-22 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f

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