Diode laser therapy system

GUDID 06976233581002

Diode laser therapy system

Hebei Newangel Technology Co., Ltd.

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• Primary Device ID: 06976233581002
• NIH Device Record Key: 65bec7a1-750c-41b5-b0cd-be9365ed83d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diode laser therapy system
• Version Model Number: ltmax
• Company DUNS: 408311018
• Company Name: Hebei Newangel Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976233581002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212978

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: 2023-04-24
• Device Publish Date: 2023-04-14