MDElite Laser and Aesthetic, LLC

Address:4041 NE LAKEWOOD WAY SUITE 180,Lees Summit,MO,64064,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (4) Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (1)

Premarket Exempt

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MDElite iProX - 00860007876806 Catalog Number :

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

Device Class : 2

Duns Number: 118440103

Premarket Exempt : No

Product Code : ONF, GEX

Prescription Use : Yes

Device Count : 1

MD Elite LaserPro - 00860007876813 Catalog Number :

Device Description : MD Elite LaserPro - Diode Laser System - FDA 510(k) K212478

Device Class : 2

Duns Number: 118440103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

iLightPro - 00860007876820 Catalog Number :

Device Description : iLightPro - Powered Laser Surgical Instrument - FDA 510(k) K190938

Device Class : 2

Duns Number: 118440103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

iProElite - 00860007876837 Catalog Number :

Device Description : iProElite - Diode Laser System - FDA 510(k) K212478

Device Class : 2

Duns Number: 118440103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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