Alpha FS90000

GUDID 07290016681062

Multi-modality system supporting IPL (Intense Pulse Light) and Laser applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions,

FORMATK SYSTEMS LTD

Multi-modality skin surface treatment system

• Primary Device ID: 07290016681062
• NIH Device Record Key: 8f191142-ee9e-4fd3-8bb5-dab0b23dbeaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alpha
• Version Model Number: FS90000
• Catalog Number: FS90000
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	07290016681062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183307

FDA Product Code

• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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

• 07290016681147 - iProElite Cart: 2024-10-28 Cart to be used with Formatk Systems Ltd Forma, iProElite
• 07290016681093 - iProElite: 2024-10-23 Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency) and Diamond Peeling applicators for various tr
• 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