iProElite

GUDID 00860007876837

iProElite - Diode Laser System - FDA 510(k) K212478

MDElite Laser and Aesthetic, LLC

Dermatological diode laser system

• Primary Device ID: 00860007876837
• NIH Device Record Key: e8cbd8e5-f00a-4fc0-bb3b-6fd1bc2970b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iProElite
• Version Model Number: iProElite
• Company DUNS: 118440103
• Company Name: MDElite Laser and Aesthetic, LLC
• 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: false
• 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	00860007876837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212478

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: 2022-07-18
• Device Publish Date: 2022-07-09

Devices Manufactured by MDElite Laser and Aesthetic, LLC

• 00860007876820 - iLightPro: 2022-07-18 iLightPro - Powered Laser Surgical Instrument - FDA 510(k) K190938
• 00860007876837 - iProElite: 2022-07-18iProElite - Diode Laser System - FDA 510(k) K212478
• 00860007876837 - iProElite: 2022-07-18 iProElite - Diode Laser System - FDA 510(k) K212478
• 00860007876813 - MD Elite LaserPro: 2022-02-07 MD Elite LaserPro - Diode Laser System - FDA 510(k) K212478
• 00860007876806 - MDElite iProX: 2022-02-02 MDElite iProX - Intense Pulsed Light Equipment - AC110V 50/60Hz 2500VA 34*57*118cm 62kg - FDA 510(k) K193328