SOLAWAVE

GUDID 00810137610436

The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage.

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Blue/red/infrared phototherapy lamp

• Primary Device ID: 00810137610436
• NIH Device Record Key: 8c9f8552-fa90-4516-876a-f92aaaafc002
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLAWAVE
• Version Model Number: 61043
• 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: false
• Serial Number: false
• 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
GS1	00810137610436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250532

FDA Product Code

• OHS: Light Based Over The Counter Wrinkle Reduction

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: 2025-07-07
• Device Publish Date: 2025-06-28

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
• 00810137610436: The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy
• 00810137610429: The LED Eye Mask, model: EY-20N is an over-the-counter light-emiting diode (LEDdevice that emits