MDElite iProX

GUDID 00860007876806

MDElite iProX - Intense Pulsed Light Equipment - AC110V 50/60Hz 2500VA 34*57*118cm 62kg - FDA 510(k) K193328

MDElite Laser and Aesthetic, LLC

Intense pulsed light skin surface treatment system

• Primary Device ID: 00860007876806
• NIH Device Record Key: 53d5865e-c9a5-426b-a395-5fec6d5943d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MDElite iProX
• Version Model Number: iProX
• 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	00860007876806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193328

FDA Product Code

• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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: 2022-02-02
• Device Publish Date: 2022-01-25

Devices Manufactured by MDElite Laser and Aesthetic, LLC

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