OMNIMAX S3

GUDID 07290110240035

The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse Light (IPL) and Infrared light (IR) for dermatological treatments by delivery of energy to the human skin.

SharpLight Technologies Ltd.

Multi-modality skin surface treatment system

• Primary Device ID: 07290110240035
• NIH Device Record Key: e780f429-9bbe-445f-aca4-38192c65ed47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNIMAX S3
• Version Model Number: OMNIMAX-S3
• Company DUNS: 533979399
• Company Name: SharpLight Technologies 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110240035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111303

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2023-05-29
• Device Publish Date: 2023-05-21

Devices Manufactured by SharpLight Technologies Ltd.

• 07290110240059 - Rapid Tight: 2023-05-30
• 07290110240073 - Rapid Peel: 2023-05-30
• 07290110240110 - Rapid DPC: 2023-05-30
• 07290110240127 - Rapid Vanish: 2023-05-30
• 07290110240134 - Rapid QS: 2023-05-30
• 07290110240035 - OMNIMAX S3: 2023-05-29The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse Light (IPL) and Infrared light (IR) for dermatological treatments by delivery of energy to the human skin.
• 07290110240035 - OMNIMAX S3: 2023-05-29 The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse Light (IPL) and Infra
• 07290110240042 - OMNIMAX S4: 2023-05-29 The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse Light (IPL) Infrared