Sheerwave Plus FS70020

GUDID 07290016681086

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

FORMATK SYSTEMS LTD

Multi-modality skin surface treatment system Multi-modality skin surface treatment system

• Primary Device ID: 07290016681086
• NIH Device Record Key: 42f3a8b5-ed99-4523-9d9f-df15867c9996
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sheerwave Plus
• Version Model Number: IPLaser 360
• Catalog Number: FS70020
• 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	07290016681086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153566

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: 2023-09-04
• Device Publish Date: 2023-08-27

Devices Manufactured by FORMATK SYSTEMS LTD

• 07290016681086 - Sheerwave Plus: 2023-09-04Multi-modality system supporting IPL (Intense Pulsed Light) and Laser applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions, Vascular Lesions
• 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