510(k) K221375
K221375 is an FDA 510(k) premarket notification submitted by Novasight , Ltd. for the device "CureSight-CS100". The FDA issued a decision of Substantially Equivalent on September 29, 2022. The device falls under product code QQU (Digital Therapy Device For Amblyopia), a Class II device regulated under 21 CFR 886.5500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2022
- Date Received
- May 12, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digital Therapy Device For Amblyopia
- Device Class
- Class II
- Regulation Number
- 886.5500
- Review Panel
- OP
- Submission Type
A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia.