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FDA 510(k), K222012, FAQ 101
FDA 510(k), K222012, FAQ 101
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510(K) Number: K222012
Device Name: FAQ 101
Manufacturer: Foreo, Inc.
Device Classification Name: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Regulation Number: 878.4420
Classification Product Code: PAY
Date Received: 07/08/2022
Decision Date: 04/05/2023
Regulation Medical Specialty: General & Plastic Surgery
Device Name: FAQ 101
Manufacturer: Foreo, Inc.
Device Classification Name: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Regulation Number: 878.4420
Classification Product Code: PAY
Date Received: 07/08/2022
Decision Date: 04/05/2023
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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