Venus Legacy CX
FDA 510(k) K143554 · Venus Concept , Ltd.
510(k) numberK143554
Submission
- Device name
- Venus Legacy CX
- Applicant
- Venus Concept , Ltd.
Sunrise, FL, US - Received
- December 15, 2014
- Decision date
- August 4, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBX – Massager, Vacuum, Radio Frequency Induced Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
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| K152790 | Venus Versa SystemONF · Traditional | 01/20/2016SE |
| 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 Legacy CX cleared by the FDA?
Venus Legacy CX (K143554) received a 510(k) decision of Substantially Equivalent on August 4, 2015, 232 days after the submission was received.
What is the product code of K143554?
The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.