Ophthalmoscopes Diagnostic Instrument Kits
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131719 FDA 510(k)
- FDA Product Code
- HLJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1570 FDA 510(k)
- Regulation Number
- 886.1570 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ophthalmoscopes Diagnostic Instrument Kits are hand-held, battery-powered devices designed for clinical examination. They incorporate illumination and viewing optics to allow for the inspection of the eye's media, including the cornea, aqueous, lens, and vitreous.
This device is regulated under FDA 510(k) clearance number K131719. It is classified as a Class 2 medical device under regulation number 886.1570.
Frequently asked questions
What is the primary purpose of these ophthalmoscope kits?
These kits are hand-held, battery-powered diagnostic instruments designed for clinical examinations. They utilize integrated illumination and viewing optics to allow clinicians to inspect the eye's media, specifically the cornea, aqueous, lens, and vitreous.
How is this device regulated?
This device is classified as a Class 2 medical device under regulation number 886.1570. It has received FDA 510(k) clearance, identified by the number K131719.
What power source does the device require?
The ophthalmoscope kits are battery-powered, which allows for the portability required for hand-held clinical use during eye examinations.
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: OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS (K131719) — FDA 510 (k ..., OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS 510(k)… - FDA.report, 510 (k) Premarket Notification, Medical Devices (Pvt) , Ltd. FDA 510 (k) Products (2013-2013)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131719 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Devices (Pvt) Ltd
- FDA Applicant
- Medical Devices (Pvt) , Ltd.
Sources (1)
- FDA 510(k) K131719 24 fields · synced Oct 6, 2026