Diode Laser Therapy System

GUDID 06973011720035

Sanhe Leifeishi Electronic Product Co.,Ltd.

Dermatological diode laser system

• Primary Device ID: 06973011720035
• NIH Device Record Key: 95dda4b8-9570-4e11-899b-9bd236646602
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diode Laser Therapy System
• Version Model Number: LFS-K2
• Company DUNS: 550747317
• Company Name: Sanhe Leifeishi Electronic Product 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	06973011720035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192569

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: 2020-05-06
• Device Publish Date: 2020-04-28

On-Brand Devices [Diode Laser Therapy System]

• 06973011720035: LFS-K2
• 06973011720028: LFS-K5
• 06973011720011: LFS-K8