K233862 is an FDA 510(k) clearance for the NUNA LUX (NUNL528), a Light Based Over The Counter Wrinkle Reduction (Class II — Special Controls, product code OHS), submitted by Premier North America, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on March 1, 2024, 86 days after receiving the submission on December 6, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K233862 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 06, 2023 |
| Decision Date | March 01, 2024 |
| Days to Decision | 86 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. |