Darwin

GUDID 00754016214134

Luvo Medical Technologies Inc

Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system 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