Piccolight E50, Piccolight E56, Eurolight E10, Eurolight E30, And Eurolight E36
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070270 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 Piccolight E50, Piccolight E56, Eurolight E10, Eurolight E30, and Eurolight E36 are battery-powered ophthalmoscopes designed for ophthalmic examination. These devices provide illumination and magnification of the retina and ocular structures, enabling clinicians to assess fundus conditions, optic disc health, and retinal vasculature. The Piccolight models feature a single aperture, while the Eurolight E36 incorporates six apertures for varied diagnostic views. Their design adheres to the classification of battery-powered ophthalmoscopes, facilitating precise retinal imaging in clinical settings.
These ophthalmoscopes are supplied as reusable devices, intended for use in clinical environments such as ophthalmology offices, hospitals, and diagnostic centers. The Piccolight handles are constructed from PA 6 GF 30%, while the Eurolight handles are made of metal. They are regulated under the FDA’s 510(k) clearance process, classified as Class II devices (HLJ), and comply with regulation number 886.1570. Sterilization and maintenance protocols must follow manufacturer guidelines to ensure proper functionality and patient safety.
Frequently asked questions
Are these ophthalmoscopes designed for single-use or reusable in clinical settings, and what materials are the handles made of?
These devices are reusable and intended for use in clinical environments like ophthalmology offices, hospitals, and diagnostic centers. The Piccolight models (E50, E56) feature handles constructed from PA 6 GF 30% (polyamide 6 with 30% glass fiber), while the Eurolight models (E10, E30, E36) have metal handles. Proper sterilization and maintenance per manufacturer guidelines are required to ensure functionality and patient safety.
What distinguishes the Eurolight E36 from the other models in terms of diagnostic flexibility?
The Eurolight E36 is unique among these models because it includes six apertures, allowing clinicians to adjust the view for varied diagnostic purposes. In contrast, the Piccolight models (E50, E56) and other Eurolight models (E10, E30) feature a single aperture, which may limit flexibility in retinal imaging.
How are these devices powered, and what regulatory pathway did they follow for FDA clearance?
These ophthalmoscopes are battery-powered, enabling portable use in clinical settings. They were cleared through the FDA’s 510(k) process under Traditional Review, classified as Class II devices (product code HLJ). The clearance was granted on November 5, 2007, with a decision code of SESE (Substantially Equivalent) to a predicate device.
What types of clinical environments are these devices intended for, and what should be considered for their maintenance?
These devices are designed for ophthalmic examination in clinical settings, including ophthalmology offices, hospitals, and diagnostic centers. Since they are reusable, maintenance and sterilization must follow manufacturer-provided guidelines to ensure proper functionality, hygiene, and patient safety. The materials (PA 6 GF 30% or metal) also influence cleaning protocols.
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: Piccolight E50,Piccolight E56,Eurolight E10, Eurolight E30, and ..., KaWe PICCOLIGHT - KaWe Medical, KAWE EUROLIGHT E10 USER MANUAL Pdf Download | ManualsLib, PDF KaWe EUROLIGHT, PICCOLIGHT Ophthalmoscope User Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070270 | Class II | Active |
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Manufacturer
- Manufacturer
- Kirchner & Wilhelm GmbH + Co KG
- FDA Applicant
- Kirchner & Wilhelm GmbH + Co.Kg
Sources (1)
- FDA 510(k) K070270 24 fields · synced Oct 6, 2026