# K221375: CureSight-CS100

- Pathway: 510(k) (Traditional)
- Applicant: Novasight, Ltd.
- Decided: Sep 29, 2022 after 140 days
- Product code: QQU (Digital Therapy Device For Amblyopia)
- Device class: 2
- Regulation: 21 CFR 886.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN210005 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN210005: Luminopia One, Luminopia, Inc. (2021) Summary page 4.

## Indications for use
The CureSight™ system is indicated for improvement in visual acuity and stereo acuity in amblyopia patients, aged 4 - <9 years, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. CureSight™ is intended for both previously treated and untreated patients and is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the anaglyph glasses during CureSight™ treatment. CureSight™ is intended for prescription use only, in an at-home environment.

Source page: https://510kreport.com/device/K221375
Methodology: https://510kreport.com/methodology