Dectro International

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Filters

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

Premarket Exempt

Clear

Apilux - 00686209171026 Catalog Number : 01-7102

Device Description : Intense Pulsed Ligh (ILP) for Light Hair Removal abd Dark Hair Removal

Device Class : 2

Duns Number: 246237945

Premarket Exempt : No

Product Code : ONF

Prescription Use : No

Device Count : 1

Apilux - 00686209171125 Catalog Number : 01-7112

Device Description : Intense Pulsed Light (IPL) for Treatment of Acne, Vascular Lesions, Pigemented L Intense Pulsed Light (IPL) for Treatment of Acne, Vascular Lesions, Pigemented Lesions, Light Hair Removal, Dark HairRemoval

Device Class : 2

Duns Number: 246237945

Premarket Exempt : No

Product Code : ONF

Prescription Use : No

Device Count : 1

Apilux - 00686209191109 Catalog Number : 01-9110

Device Description : Intense Pulsed Light unit (IPL) 120Vac

Device Class : 2

Duns Number: 246237945

Premarket Exempt : No

Product Code : ONF

Prescription Use : No

Device Count : 1

Apilux - 00686209192205 Catalog Number : 01-9220

Device Description : Intense Pulsed Light unit (IPL) 220Vac

Device Class : 2

Duns Number: 246237945

Premarket Exempt : No

Product Code : ONF

Prescription Use : No

Device Count : 1

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