EndyMed Contour Handpiece
FDA 510(k) K161199 · Endymed Medical, Ltd.
510(k) numberK161199
Submission
- Device name
- EndyMed Contour Handpiece
- Applicant
- Endymed Medical, Ltd.
Caesarea, IL - Received
- April 28, 2016
- Decision date
- August 1, 2016
- 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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| K242996 | EndyMed PRO MAXGEI · Traditional | 06/10/2025SE |
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| K161715 | EndyGelGYB · Traditional | 02/07/2017SE |
| K130501 | IntensifOUH · Traditional | 03/13/2014SE |
| K120513 | Glow by EndymedOUH · Traditional | 05/08/2012SE |
| K101510 | Fractional Skin Resurfacing (FSR) ApplicatorOUH · Traditional | 02/17/2011SE |
Questions and answers
When was EndyMed Contour Handpiece cleared by the FDA?
EndyMed Contour Handpiece (K161199) received a 510(k) decision of Substantially Equivalent on August 1, 2016, 95 days after the submission was received.
What is the product code of K161199?
The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.