Solawave

GUDID 00850035134887

The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use.

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Cosmetic red-light phototherapy system, home-use

• Primary Device ID: 00850035134887
• NIH Device Record Key: 2892412b-f53c-4869-8cf6-0655d0d4f025
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solawave
• Version Model Number: HD-15A
• Company DUNS: 543062382
• Company Name: Shenzhen Kaiyan Medical Equipment Co,. Ltd
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850035134887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232863

FDA Product Code

• NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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: 2024-02-07
• Device Publish Date: 2024-01-30

On-Brand Devices [Solawave ]

• 00850035134887: The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation an
• 00850035134368: The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face a