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510(k) Data Aggregation
K Number
K221375Device Name
CureSight-CS100
Manufacturer
NovaSight Ltd.
Date Cleared
2022-09-29
(140 days)
Product Code
QQU
Regulation Number
886.5500Why did this record match?
Applicant Name (Manufacturer) :
NovaSight Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CureSight™ system is indicated for improvement in visual acuity in amblyopia patients, aged 4 - < > 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™ is intended for prescription use only, in an at-home environment.
Device Description
The CureSight™ system is an eye-tracking-based system aimed for improving visual acuity and stereo acuity under dichoptic conditions. The technology is based on real-time eye tracking and separation of the visual stimuli presented on a monitor into two separate digital channels, one for each eye. Using this dichoptic method, any streamed video content can be tailored individually per eye and then presented simultaneously to each eye.
During the treatment, dichoptic anaglyph (red-blue) glasses that are part of the CureSight system are to be worn over the habitual spectacle correction.
The CureSight™ system comprises the following components/modules:
- CureSight-CS100 device (console and anaglyph glasses) ●
- CureSight Web-App/Portal
CureSight™ system is aimed for improving visual acuity and stereo acuity under dichoptic conditions, using digital content in pediatric patients (age 4 to <9 years) suffering from amblyopia, under a supervision of eye care provider.
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