Magma Spark Cart FS80001

GUDID 07290016681123

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

FORMATK SYSTEMS LTD

Electromechanical device/system transport trolley

• Primary Device ID: 07290016681123
• NIH Device Record Key: a6d4486e-42c5-4e38-a279-16c658fa3e12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magma Spark Cart
• Version Model Number: FS80001
• Catalog Number: FS80001
• Company DUNS: 532396673
• Company Name: FORMATK SYSTEMS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016681123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183307

FDA Product Code

• BZN: Cart, Emergency, Cardiopulmonary (Excluding Equipment)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-16
• Device Publish Date: 2018-12-16

Devices Manufactured by FORMATK SYSTEMS LTD

• 07290016681086 - Sheerwave Plus: 2023-09-04 Multi-modality system supporting IPL (Intense Pulsed Light) and Laser applicators for various treatments such as Hair Removal, A
• 07290016681079 - DioBreeze: 2021-07-05 DioBreeze system supporting Laser applicators indicated for various treatments such as Hair Removal, Permanent Hair Reduction an
• 07290016681130 - DioBreeze Cart: 2021-07-05 Cart to be used with Formatk Systems Ltd Magma Spark, Magma Spark Pro, Magma Spark Plus, Alpha, DioBreeze (Desktop) featuring Mo
• 07290016681437 - HR-Mini: 2021-07-05 Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments
• 07290016681444 - HR-Max: 2021-07-05 Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments
• 07290016681017 - Forma Light: 2020-02-24 System supporting IPL (Intense Pulsed Light) applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions
• 07290016681048 - Magma Spark Pro: 2019-01-16 Multi-modality system supporting IPL (Intense Pulse Light) and Laser applicators for various treatments such as Hair Removal, Ac
• 07290016681055 - Magma Spark Plus: 2019-01-16 Multi-modality system supporting IPL (Intense Pulse Light) and Laser applicators for various treatments such as Hair Removal, Ac