EnergyLounger

GUDID 06970006971212

Mi is used to reduce the circumference of the hips, waist and thighs and is indicated for use as a non. invasive dermatological. M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment offull-face wrinkles. M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for thepurpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness.minor arthritis, pain or muscle spasm, the temporary increase in local blood circulation, and the temporaryrelaxation of muscles.

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Blue/red/infrared phototherapy lamp

• Primary Device ID: 06970006971212
• NIH Device Record Key: 3a815013-6c91-4cd4-8277-a01970ab306f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnergyLounger
• Version Model Number: TY-01
• 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	06970006971212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241947

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

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