Rapid Tight

GUDID 07290110240059

SharpLight Technologies Ltd.

Multi-modality skin surface treatment system

• Primary Device ID: 07290110240059
• NIH Device Record Key: ed89be5f-5c5c-4f10-adb3-bdb769142504
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid Tight
• Version Model Number: RAPID–TIGHT
• 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	07290110240059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173169

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: 2023-05-30
• Device Publish Date: 2023-05-22

Devices Manufactured by SharpLight Technologies Ltd.

• 07290110240059 - Rapid Tight: 2023-05-30
• 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: 2023-05-29 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