HR-Max FS80022

GUDID 07290016681444

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

FORMATK SYSTEMS LTD

Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece
Primary Device ID07290016681444
NIH Device Record Key13ca298b-4e86-4ee0-a4e3-f127461d9839
Commercial Distribution StatusIn Commercial Distribution
Brand NameHR-Max
Version Model NumberFS80022
Catalog NumberFS80022
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
GS107290016681444 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-05
Device Publish Date2021-06-25

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07290016681444 - HR-Max2021-07-05Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments
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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
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