Magma Spark FS80000

GUDID 07290016681031

Magma Spark system supprting Laser applicators indicated for various treatments such as Hair Removal, Permanent Hair Reduction and pseudofolliculitis

FORMATK SYSTEMS LTD

Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system
Primary Device ID07290016681031
NIH Device Record Keyecd1a43a-4530-42bc-b918-44ee7d160a22
Commercial Distribution StatusIn Commercial Distribution
Brand NameMagma Spark
Version Model NumberFS80000
Catalog NumberFS80000
Company DUNS532396673
Company NameFORMATK SYSTEMS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016681031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-30

Devices Manufactured by FORMATK SYSTEMS LTD

07290016681086 - Sheerwave Plus2023-09-04 Multi-modality system supporting IPL (Intense Pulsed Light) and Laser applicators for various treatments such as Hair Removal, A
07290016681079 - DioBreeze2021-07-05 DioBreeze system supporting Laser applicators indicated for various treatments such as Hair Removal, Permanent Hair Reduction an
07290016681130 - DioBreeze Cart2021-07-05 Cart to be used with Formatk Systems Ltd Magma Spark, Magma Spark Pro, Magma Spark Plus, Alpha, DioBreeze (Desktop) featuring Mo
07290016681437 - HR-Mini2021-07-05 Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments
07290016681444 - HR-Max2021-07-05 Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments
07290016681017 - Forma Light2020-02-24 System supporting IPL (Intense Pulsed Light) applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions
07290016681048 - Magma Spark Pro2019-01-16 Multi-modality system supporting IPL (Intense Pulse Light) and Laser applicators for various treatments such as Hair Removal, Ac
07290016681055 - Magma Spark Plus2019-01-16 Multi-modality system supporting IPL (Intense Pulse Light) and Laser applicators for various treatments such as Hair Removal, Ac
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