Dr Naomi

GUDID 00856957008022

The LED Light Therapy Mask (Models: MK-04) is an over the counter device that is intended forthe use in the treatment of full-face wrinkles.

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Blue/red/infrared phototherapy lamp

• Primary Device ID: 00856957008022
• NIH Device Record Key: e07b1ca0-07e0-4ca9-9e8f-5b603ac5f932
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dr Naomi
• Version Model Number: MK-04
• 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	00856957008022 [Primary]

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

Devices Manufactured by Shenzhen Kaiyan Medical Equipment Co,. Ltd

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• 00856957008022 - Dr Naomi: 2025-07-07The LED Light Therapy Mask (Models: MK-04) is an over the counter device that is intended forthe use in the treatment of full-face wrinkles.
• 00856957008022 - Dr Naomi: 2025-07-07 The LED Light Therapy Mask (Models: MK-04) is an over the counter device that is intended forthe use in the treatment of full-fa
• 05060282690301 - Lustre: 2025-07-07 The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001) is an Over-the-Counter (OTC) device intended for treatment of mi