Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
FDA 510(k) K151296 · Bios S.R.L.
510(k) numberK151296
Submission
- Device name
- Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
- Applicant
- Bios S.R.L.
Vimodrone, IT - Received
- May 15, 2015
- Decision date
- November 19, 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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Questions and answers
When was Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) cleared by the FDA?
Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) (K151296) received a 510(k) decision of Substantially Equivalent on November 19, 2015, 188 days after the submission was received.
What is the product code of K151296?
The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.