The following data is part of a premarket notification filed by Led Intellectual Properties Llc with the FDA for Lightstim Elipsa.
| Device ID | K212771 |
| 510k Number | K212771 |
| Device Name: | LightStim Elipsa |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | LED Intellectual Properties LLC 16552 Von Karman Ave Irvine, CA 92606 |
| Contact | Chase Marchese |
| Correspondent | Chase Marchese LED Intellectual Properties LLC 16552 Von Karman Ave Irvine, CA 92606 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-31 |
| Decision Date | 2022-01-26 |