BVLASER

GUDID 06974851083014

The Intense Pulsed Light Treatment System (Model: LK-PT) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Nanjing Bestview Laser S&T Co.,Ltd.

Intense pulsed light skin surface treatment system

• Primary Device ID: 06974851083014
• NIH Device Record Key: 1d7ed88f-a815-4b9d-9f25-f69239489294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BVLASER
• Version Model Number: LK-PT
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974851083014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242440

FDA Product Code

• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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: 2024-12-05
• Device Publish Date: 2024-11-27

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
• 06974851083014: The Intense Pulsed Light Treatment System (Model: LK-PT) is indicated for use in surgical and ae