FDA 510(k), K212947, Trinity Plus Wrinkle Reducer
FDA 510(k), K212947, Trinity Plus Wrinkle Reducer
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510(K) Number: K212947
Device Name: Trinity Plus Wrinkle Reducer
Manufacturer: Carol Cole Company dba NuFACE
Device Classification Name: Light Based Over The Counter Wrinkle Reduction
Regulation Number: 878.4810
Classification Product Code: OHS
Date Received: 09/15/2021
Decision Date: 04/02/2022
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Trinity Plus Wrinkle Reducer
Manufacturer: Carol Cole Company dba NuFACE
Device Classification Name: Light Based Over The Counter Wrinkle Reduction
Regulation Number: 878.4810
Classification Product Code: OHS
Date Received: 09/15/2021
Decision Date: 04/02/2022
Regulation Medical Specialty: General & Plastic Surgery
- 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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