ketrina

GUDID 06975587680010

Hunan Guangye Biotechnology Co., Ltd.

Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp

• Primary Device ID: 06975587680010
• NIH Device Record Key: 72020b2b-feb7-4afc-a315-c111cca03904
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ketrina
• Version Model Number: KFB265
• Company DUNS: 404145347
• Company Name: Hunan Guangye Biotechnology 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: true
• 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	06975587680010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221151

FDA Product Code

• OLP: Over-The-Counter Powered Light Based Laser For Acne

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: 2022-08-02
• Device Publish Date: 2022-07-25

Devices Manufactured by Hunan Guangye Biotechnology Co., Ltd.

• 06975587680034 - Nood: 2023-08-04
• 06975587680010 - ketrina: 2022-08-02
• 06975587680010 - ketrina: 2022-08-02
• 06975587680003 - Nood: 2022-07-26