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) (6) Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (6) Cart, Emergency, Cardiopulmonary (Excluding Equipment) (BZN) (2) Brush, Dermabrasion, Powered (GFE) (1) Lamp, Infrared, Therapeutic Heating (ILY) (1) Massager, Vacuum, Radio Frequency Induced Heat (PBX) (1)

Premarket Exempt

Clear

Forma - 07290016681000 Catalog Number : FS10000

Device Description : Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency) and Diamond Peeling applicators for various treatmentssuch as Hair Removal, Acne, Pigmented Lesions, Skin Dermabrasion

Device Class : 1

Duns Number: 532396673

Premarket Exempt : No

Product Code : PBX, ONF, ILY, GFE

Prescription Use : Yes

Device Count : 1

Forma Light - 07290016681017 Catalog Number : FS60000

Device Description : System supporting IPL (Intense Pulsed Light) applicators for various treatmentss System supporting IPL (Intense Pulsed Light) applicators for various treatmentssuch as Hair Removal, Acne, Pigmented Lesions

Device Class : 2

Duns Number: 532396673

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Magma - 07290016681024 Catalog Number : FS70000

Device Description : Multi-modality system supporting IPL (Intense Pulsed Light) and Laser applicator Multi-modality system supporting IPL (Intense Pulsed Light) and Laser applicators for various treatmentssuch as Hair Removal, Acne, Pigmented Lesions, Vascular lesions

Device Class : 2

Duns Number: 532396673

Premarket Exempt : No

Product Code : ONF, GEX

Prescription Use : Yes

Device Count : 1

Magma Spark - 07290016681031 Catalog Number : FS80000

Device Description : Magma Spark system supprting Laser applicators indicated for various treatments Magma Spark system supprting Laser applicators indicated for various treatments such as Hair Removal, Permanent Hair Reduction and pseudofolliculitis babae (PFB)

Device Class : 2

Duns Number: 532396673

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Magma Spark Pro - 07290016681048 Catalog Number : FS90000

Device Description : Multi-modality system supporting IPL (Intense Pulse Light) and Laser applicators Multi-modality system supporting IPL (Intense Pulse Light) and Laser applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions, Vascular Lesions

Device Class : 2

Duns Number: 532396673

Premarket Exempt : No

Product Code : ONF, GEX

Prescription Use : Yes

Device Count : 1

Magma Spark Plus - 07290016681055 Catalog Number : FS90000

Device Class : 2

Duns Number: 532396673

Premarket Exempt : No

Product Code : ONF, GEX

Prescription Use : Yes

Device Count : 1

Alpha - 07290016681062 Catalog Number : FS90000

Device Class : 2

Duns Number: 532396673

Premarket Exempt : No

Product Code : ONF, GEX

Prescription Use : Yes

Device Count : 1

DioBreeze - 07290016681079 Catalog Number : FS80020

Device Description : DioBreeze system supporting Laser applicators indicated for various treatments s DioBreeze system supporting Laser applicators indicated for various treatments such as Hair Removal, Permanent Hair Reduction and pseudofolliculitis barbae (PFB)

Device Class : 2

Duns Number: 532396673

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Forma Cart - 07290016681109 Catalog Number : FS10001

Device Description : Cart to be used with Formatk Systems Ltd Forma system (Dsktop) featuring Mobile system

Device Class : 1

Duns Number: 532396673

Premarket Exempt : No

Product Code : BZN

Prescription Use : Yes

Device Count : 1

Magma Spark Cart - 07290016681123 Catalog Number : FS80001

Device Description : Cart to be used with Formatk Systems Ltd Magma Spark, Magma Spark Pro, Magma Spa Cart to be used with Formatk Systems Ltd Magma Spark, Magma Spark Pro, Magma Spark Plus, Alpha (Desktop) featuring Mobile system

Device Class : 1

Duns Number: 532396673

Premarket Exempt : No

Product Code : BZN

Prescription Use : Yes

Device Count : 1

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