Bilens

GUDID 06976573482106

Picosecond Nd:YAG Laser Systems

Shanghai Bele Medical Technology Co., Ltd.

Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 06976573482106
• NIH Device Record Key: 98dd8754-5b82-46ed-8ba0-999598414d1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bilens
• Version Model Number: BL-C10
• Company DUNS: 724477410
• Company Name: Shanghai Bele Medical Technology 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976573482106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240386

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: 2024-12-02
• Device Publish Date: 2024-11-24

On-Brand Devices [Bilens]

• 06976573489105: Multi-function Platform Systems
• 06976573482106: Picosecond Nd:YAG Laser Systems