ST FS10011

GUDID 07290016681277

Radiofrequency Applicator to be used with Formatk Systems Ltd supporting systems for minor muscle aches and pain treatments

FORMATK SYSTEMS LTD

Radio-frequency skin contouring system applicator, bipolar
Primary Device ID07290016681277
NIH Device Record Key0a7abea0-d7a5-473d-a9e6-f1f4266ddf9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameST
Version Model NumberFS10011
Catalog NumberFS10011
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 Datefalse
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
GS107290016681277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBXMassager, Vacuum, Radio Frequency Induced Heat

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 Date2017-08-18

Devices Manufactured by FORMATK SYSTEMS LTD

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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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