K241102 is an FDA 510(k) clearance for the Luna 4 plus. This device is classified as a Light Based Over The Counter Wrinkle Reduction (Class II - Special Controls, product code OHS).
Submitted by Foreo, Inc. (Las Vegas, US). The FDA issued a Cleared decision on August 20, 2024, 120 days after receiving the submission on April 22, 2024.
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 | K241102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2024 |
| Decision Date | August 20, 2024 |
| Days to Decision | 120 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. |