The following data is part of a premarket notification filed by Light Tree Ventures Europe B.v. with the FDA for Led Eye Perfector, Model: Ey-36a, Ey-36b.
| Device ID | K221444 |
| 510k Number | K221444 |
| Device Name: | LED Eye Perfector, Model: EY-36A, EY-36B |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Light Tree Ventures Europe B.V. Laan Van Ypenburg 108, 2497 GC The Hague, NL |
| Contact | Kim Laurens |
| Correspondent | Kim Laurens Light Tree Ventures Europe B.V. Laan Van Ypenburg 108, 2497 GC The Hague, NL |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-18 |
| Decision Date | 2022-12-08 |