Venus Versa System
FDA 510(k) K152790 · Venus Concept , Ltd.
Submission
- Device name
- Venus Versa System
- Applicant
- Venus Concept , Ltd.
Sunrise, FL, US - Received
- September 25, 2015
- Decision date
- January 20, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONF – Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon…
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| K233307 | Intensity Pulsed Light Therapy SystemONF · Traditional | Beijing Adss Development Co., Ltd. | 03/15/2024SE |
More from Beijing Adss Development Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252845 | Venus Nova (FP-2001)GEI · Traditional | 11/06/2025SE |
| K232192 | Venus Versa PRO SystemONF · Special | 09/11/2023SE |
| K162765 | Venus Velocity Diode Laser SystemGEX · Traditional | 01/11/2017SE |
| K153717 | Venus Versa SystemONF · Traditional | 03/21/2016SE |
| K143554 | Venus Legacy CXPBX · Traditional | 08/04/2015SE |
| K150161 | Venus Viva SR DeviceGEI · Traditional | 05/12/2015SE |
| K140629 | Venus SWAN(MP)2GEI · Traditional | 06/25/2014SE |
| K111670 | Venus Freeze (MP)2 SystemGEI · Traditional | 03/02/2012SE |
| K111784 | Venus Swan SystemGEI · Traditional | 10/07/2011SE |
| K100586 | Venus Freeze SystemGEI · Traditional | 11/29/2010SE |
Questions and answers
When was Venus Versa System cleared by the FDA?
Venus Versa System (K152790) received a 510(k) decision of Substantially Equivalent on January 20, 2016, 117 days after the submission was received.
What is the product code of K152790?
The FDA product code is ONF – Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, a Class II (moderate risk) device regulated under 21 CFR 878.4810.