iProElite FS10000-3

GUDID 07290016681093

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

FORMATK SYSTEMS LTD

Multi-modality skin surface treatment system
Primary Device ID07290016681093
NIH Device Record Keyb87c6abb-4de0-4f1c-854e-0be39e89583a
Commercial Distribution StatusIn Commercial Distribution
Brand NameiProElite
Version Model NumberFS10000-3
Catalog NumberFS10000-3
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
GS107290016681093 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-23
Device Publish Date2024-10-15

Devices Manufactured by FORMATK SYSTEMS LTD

07290016681147 - iProElite Cart2024-10-28 Cart to be used with Formatk Systems Ltd Forma, iProElite
07290016681093 - iProElite2024-10-23Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency) and Diamond Peeling applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions, Skin Dermabrasion
07290016681093 - iProElite2024-10-23 Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency) and Diamond Peeling applicators for various tr
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
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