S-590 FS90013

GUDID 07290016681376

IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for the treatment of Reduction of unwanted hair, Pigmente

FORMATK SYSTEMS LTD

Light-energy skin surface treatment system applicator

• Primary Device ID: 07290016681376
• NIH Device Record Key: b3bb12f5-b1e8-4c0b-8874-45e9d27e7282
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-590
• Version Model Number: FS90013
• Catalog Number: FS90013
• 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: 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	07290016681376 [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