K221444 is an FDA 510(k) clearance for the LED Eye Perfector, model: EY-36A, EY-36B, a Light Based Over The Counter Wrinkle Reduction (Class II — Special Controls, product code OHS), submitted by Light Tree Ventures Europe B.V. (Den Haag, NL). The FDA issued a Cleared decision on December 8, 2022, 204 days after receiving the submission on May 18, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K221444 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 18, 2022 |
| Decision Date | December 08, 2022 |
| Days to Decision | 204 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. |