The following data is part of a premarket notification filed by Luminopia, Inc. with the FDA for Luminopia One.
| Device ID | K221659 |
| 510k Number | K221659 |
| Device Name: | Luminopia One |
| Classification | Digital Therapy Device For Amblyopia |
| Applicant | Luminopia, Inc. 955 Massachusetts Ave #335 Cambridge, MA 02139 |
| Contact | Scott Xiao |
| Correspondent | Scott Xiao Luminopia, Inc. 955 Massachusetts Ave #335 Cambridge, MA 02139 |
| Product Code | QQU |
| CFR Regulation Number | 886.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-08 |
| Decision Date | 2022-11-04 |