Solar Wave 16 SW16

GUDID G710SW1603

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.

SUNSHINE USA, LLC

Ultraviolet tanning device

• Primary Device ID: G710SW1603
• NIH Device Record Key: f333d024-3d1f-4505-b59a-5f6efd536269
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solar Wave 16
• Version Model Number: SW16
• Catalog Number: SW16
• Company DUNS: 104258633
• Company Name: SUNSHINE USA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G710SW160 [Primary]
HIBCC	G710SW1603 [Package]; Contains: G710SW160; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152423

FDA Product Code

• LEJ: Booth, Sun Tan

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-03
• Device Publish Date: 2025-06-25