Ultimate Contour, Ultimate Contour Mini
FDA 510(k) K201475 · CAO Group, Inc.
510(k) numberK201475
Submission
- Device name
- Ultimate Contour, Ultimate Contour Mini
- Applicant
- CAO Group, Inc.
West Jordan, UT, US - Received
- June 3, 2020
- Decision date
- October 28, 2020
- 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 Ultimate Contour, Ultimate Contour Mini cleared by the FDA?
Ultimate Contour, Ultimate Contour Mini (K201475) received a 510(k) decision of Substantially Equivalent on October 28, 2020, 147 days after the submission was received.
What is the product code of K201475?
The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.