Artemis Diode Laser System

GUDID 06976812430127

Rhein Laser Technologies Co.,Ltd.

Dermatological diode laser system

• Primary Device ID: 06976812430127
• NIH Device Record Key: bf2cd0f3-2f58-4f37-aa09-bc00d88034c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Artemis Diode Laser System
• Version Model Number: RL-S20S-TWC
• Company DUNS: 704587822
• Company Name: Rhein Laser Technologies 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: true
• Serial Number: true
• Manufacturing Date: true
• 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	06976812430127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233756

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: 2024-09-23
• Device Publish Date: 2024-09-14

On-Brand Devices [Artemis Diode Laser System]

• 06976812430141: RL-S20S-755
• 06976812430134: RL-S20S-810B
• 06976812430127: RL-S20S-TWC