HIGH TECHNOLOGY PRODUCTS SL

Address:Carrer del Gall, 22,Esplugues de Llobregat Barcelona,ES

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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) (2)

Premarket Exempt

Clear

primelase excellence - 08437020651011 Catalog Number : 521028

Device Description : PRIMELASE diode laser hair removal system with 755nm, 810nm and 810 – 1060nm app PRIMELASE diode laser hair removal system with 755nm, 810nm and 810 – 1060nm applicators include:• Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.• Treatment of Pseudofolliculitis barbae (PFB)

Device Class : 2

Duns Number: 462514006

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

elysion-pro - 08437020651141 Catalog Number : 522040

Device Description : ELYSION diode laser hair removal system with 755nm and 810nm and applicators inc ELYSION diode laser hair removal system with 755nm and 810nm and applicators include: • Hair Removal withStatic and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in thenumber of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. • Treatment ofPseudofolliculitis barbae (PFB)