K212155 is an FDA 510(k) clearance for the TheraFace LED. This device is classified as a Light Based Over The Counter Wrinkle Reduction (Class II - Special Controls, product code OHS).
Submitted by Theragun, Inc. (Los Angeles, US). The FDA issued a Cleared decision on December 21, 2021, 162 days after receiving the submission on July 12, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided..
| 510(k) Number | K212155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2021 |
| Decision Date | December 21, 2021 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OHS - Light Based Over The Counter Wrinkle Reduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided. |