Identifiers
- 510(k) Number
- K173169 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rapid Family is a device for aesthetic medical treatments, including skin rejuvenation, vascular and pigmented lesion removal, body contouring, and hair removal. It is manufactured by SharpLight Technologies Ltd. and represents a multi-technology solution designed to deliver clinical results.
The device is supplied by SharpLight Technologies Ltd. and has received FDA 510(k) clearance with the product code GEX. It is intended for use in general and plastic surgery applications, with the model number K173169. No information regarding sterility, single-use or reusable status, MRI safety, or sizes is provided in the data.
Frequently asked questions
What is the Rapid Family device used for?
The Rapid Family is a multi-technology aesthetic medical device designed for treatments including skin rejuvenation, vascular and pigmented lesion removal, body contouring, and hair removal. It is intended for use in general and plastic surgery applications.
What is the regulatory status of the Rapid Family device?
The Rapid Family has received FDA 510(k) clearance with product code GEX. It was determined to be substantially equivalent to predicate devices for aesthetic treatments in general and plastic surgery applications.
Is the Rapid Family device supplied sterile or for single-use?
The device data does not specify whether the Rapid Family is supplied sterile or if it is designed for single-use or reuse. This information would need to be obtained directly from the manufacturer, SharpLight Technologies Ltd.
What model number and manufacturer information is available for the Rapid Family?
The Rapid Family is manufactured by SharpLight Technologies Ltd. with model number K173169. The company is located at 33 Lazarov St., Rishon Le Zion, Israel. For specific inquiries, contact Ilan Sharon at the provided address.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Rapid Family 510 (k) FDA Premarket Notification K173169 SharpLight ..., SharpLight Technologies - SharplightSharplight, PDF RAPIDTIGHT - sharplight.com, PDF A Technological Combination That Improves Your Expectations
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173169 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SharpLight Technologies Ltd.
- FDA Applicant
- Sharplight Technologies, Ltd.
Sources (1)
- FDA 510(k) K173169 24 fields · synced Sep 22, 2026