Identifiers
- 510(k) Number
- K221329 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)
The Eyer Retinal Camera NM-STD is an ophthalmic, AC-powered camera device classified as a retinal camera. It is substantially equivalent to a predicate device and has been cleared via the traditional 510(k) pathway.
The device is supplied by Phelcom Technologies and is authorized under FDA 510(k) clearance K221329. It is intended for use in ophthalmic settings for retinal imaging.
Frequently asked questions
What is the Eyer Retinal Camera NM-STD used for?
The Eyer Retinal Camera NM-STD is intended for use in ophthalmic settings to capture retinal images, enabling clinicians to visualize and document the retina for diagnostic and monitoring purposes.
How is the Eyer Retinal Camera NM-STD powered and supplied?
The device is AC-powered, meaning it requires connection to an electrical outlet for operation, and is supplied directly by Phelcom Technologies as the manufacturer.
What regulatory pathway was used for the Eyer Retinal Camera NM-STD?
The Eyer Retinal Camera NM-STD received FDA 510(k) clearance through the traditional pathway, identified by clearance number K221329, indicating 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. Sources consulted: Non-mydriatic retinal camera - Eyer - Phelcom Technologies - retinal ..., Eyer2 Essential - PHELCOM Technologies, PHELCOM Technologies, Eyer - The high quality portable retinal camera | Allm Inc. - Shaping ..., Eyer Retinal Camera NM-STD (K221329) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221329 | Class II | Active |
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Manufacturer
- Manufacturer
- Phelcom Technologies
Sources (1)
- FDA 510(k) K221329 24 fields · synced Sep 27, 2026