K230042 is an FDA 510(k) clearance for the Q-Rejuvalight Pro Facewear (Model: P19-0023), a Light Based Over The Counter Wrinkle Reduction (Class II — Special Controls, product code OHS), submitted by Light Tree Ventures Europe B.V. (Hague, NL). The FDA issued a Cleared decision on April 28, 2023, 112 days after receiving the submission on January 6, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K230042 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 06, 2023 |
| Decision Date | April 28, 2023 |
| Days to Decision | 112 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. |