Darwin

GUDID 00754016214134

Luvo Medical Technologies Inc

Dermatological diode laser system

• Primary Device ID: 00754016214134
• NIH Device Record Key: e1907bd0-e3c7-4eec-9325-f56ec437fb91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Darwin
• Version Model Number: ESK-3272LV
• Company DUNS: 204046564
• Company Name: Luvo Medical Technologies Inc
• 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	00754016214134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203728

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: 2022-10-24
• Device Publish Date: 2022-10-14

Devices Manufactured by Luvo Medical Technologies Inc

• 00754016214134 - Darwin: 2022-10-24
• 00754016214134 - Darwin: 2022-10-24
• 00754016214158 - Darwin IPL Handpiece: 2022-10-24
• 00754016214165 - Darwin Diode Laser Handpiece: 2022-10-24
• 00754016214172 - RF Microneedling Handpiece: 2022-10-24
• 00754016214189 - Darwin RF Thermal: 2022-10-24
• 00754016214127 - World PRP: 2021-08-19
• 00754016214028 - Bare 808: 2021-06-10
• 00754016214035 - BARE: 808 HANDPIECE: 2021-06-10