Identifiers
- 510(k) Number
- K102651 FDA 510(k)
- FDA Product Code
- HKI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1120 FDA 510(k)
- Regulation Number
- 886.1120 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
An ophthalmic, AC-powered camera device used for pediatric vision screening. It captures images to allow accurate screening for potentially serious vision abnormalities.
Supplied as a reusable device for use in healthcare settings. It is authorized under FDA 510(k) clearance K102651 and classified as a Class II device under regulation number 886.1120.
Frequently asked questions
What is the ISCREEN VISION SCREENER used for?
The ISCREEN VISION SCREENER is an ophthalmic, AC-powered camera device used for pediatric vision screening. It captures images to allow accurate screening for potentially serious vision abnormalities, helping clinicians detect issues early in children.
How is the ISCREEN VISION SCREENER supplied and is it reusable?
The ISCREEN VISION SCREENER is supplied as a reusable device for use in healthcare settings. It is designed for repeated use after appropriate cleaning and disinfection between patients, making it suitable for clinical environments where multiple screenings are performed.
What regulatory authorization does the ISCREEN VISION SCREENER have?
The ISCREEN VISION SCREENER is authorized under FDA 510(k) clearance K102651 and is classified as a Class II device under regulation number 886.1120. This indicates it has been found substantially equivalent to a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: About Us - iScreen Vision, iScreen Vision - Digital Pediatric Vision Screening - Photoscreening Device, iScreen Vision 2026 Company Profile: Valuation, Funding & Investors ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102651 | Class II | Active |
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Manufacturer
- Manufacturer
- Iscreen Vision, Inc.
Sources (1)
- FDA 510(k) K102651 24 fields · synced Sep 26, 2026