FORMATK SYSTEMS LTD

Address:3 Hayozma St.,Tirat Hacarmel Northern,IL

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

Premarket Exempt

Clear

L-650 - 07290016681390 Catalog Number : FS90015

Device Description : IPL (Intense Pulsed Light ) Applicator to be used with Formatk Systems Ltd suppo IPL (Intense Pulsed Light ) Applicator to be used with Formatk Systems Ltd supporting systems for the treatment of Pigmented lesions and removal of unwanted hair

Device Class : 2

Duns Number: 532396673

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

HR-Mini - 07290016681437 Catalog Number : FS80021

Device Description : Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments

Device Class : 2

Duns Number: 532396673

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HR-Max - 07290016681444 Catalog Number : FS80022

Device Class : 2

Duns Number: 532396673

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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