BVLASER

GUDID 06974851081010

The Diode Laser Machine (Model: BM-100) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Nanjing Bestview Laser S&T Co.,Ltd.

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• Primary Device ID: 06974851081010
• NIH Device Record Key: 973f27d8-ccd1-4c54-8244-65cca8614cb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BVLASER
• Version Model Number: BM-100
• Company DUNS: 618918496
• Company Name: Nanjing Bestview Laser S&T 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974851081010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211335

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [BVLASER]

• 06974851082017: The CO2 Laser Machine is used for human tissue vaporization, coagulation in dermatology and plas
• 06974851081010: The Diode Laser Machine (Model: BM-100) is intended for hair removal, permanent hair reduction o