GUDID 06974746830013

Ningbo Hesi Electronics Co., Ltd.

Blue/red/infrared phototherapy lamp

• Primary Device ID: 06974746830013
• NIH Device Record Key: c1aa56aa-f75b-45c3-909e-93181771695d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: HK209
• Company DUNS: 415478393
• Company Name: Ningbo Hesi Electronics 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974746830013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200983

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: 2021-09-21
• Device Publish Date: 2021-09-13

Devices Manufactured by Ningbo Hesi Electronics Co., Ltd.

• 06974746830006 - NA: 2021-09-21
• 06974746830013 - NA: 2021-09-21
• 06974746830013 - NA: 2021-09-21