K230124 is an FDA 510(k) clearance for the LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001). This device is classified as 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 March 15, 2023, 57 days after receiving the submission on January 17, 2023.
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 | K230124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2023 |
| Decision Date | March 15, 2023 |
| Days to Decision | 57 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. |