Identifiers
- 510(k) Number
- K180306 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)
Nexy is an ophthalmic, AC-powered camera device. It is substantially equivalent to a predicate device and classified under product code HKI.
The device is manufactured by Next Sight Srl and received FDA 510(k) clearance via the traditional pathway on June 8, 2018, under K180306. It is intended for use in ophthalmic settings as specified in its authorization and device classification.
Frequently asked questions
What is the Nexy device used for?
The Nexy device is intended for use in ophthalmic settings as specified in its FDA 510(k) authorization and device classification under product code HKI, which covers ophthalmic cameras.
How is the Nexy device powered and what type of device is it?
Nexy is an AC-powered ophthalmic camera device, meaning it requires connection to an alternating current power source to operate and is designed specifically for imaging in eye care environments.
When did Nexy receive FDA clearance and under which pathway?
Nexy received FDA 510(k) clearance via the traditional pathway on June 8, 2018, under submission number K180306, confirming it is 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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180306 | Class II | Active |
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Manufacturer
- Manufacturer
- Next Sight Srl
Sources (1)
- FDA 510(k) K180306 24 fields · synced Sep 23, 2026