The following data is part of a premarket notification filed by Novasight Ltd. with the FDA for Curesight-cs100.
| Device ID | K221375 |
| 510k Number | K221375 |
| Device Name: | CureSight-CS100 |
| Classification | Digital Therapy Device For Amblyopia |
| Applicant | NovaSight Ltd. 1 Hayarden St. Airport City, IL 7019801 |
| Contact | Ran Yam |
| Correspondent | Lee Kramm Regulatory Pathways Group, Inc. 340 S. Lemon Ave. #2471 Walnut, CA 91789 |
| Product Code | QQU |
| CFR Regulation Number | 886.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-12 |
| Decision Date | 2022-09-29 |