Slit Lamp BO 900, BQ 900, BP900
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100202 FDA 510(k)
- FDA Product Code
- HJO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1850 FDA 510(k)
- Regulation Number
- 886.1850 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Slit Lamp BO 900, BQ 900, and BP900 are biomicroscopes designed for ophthalmic examination. These devices use a slit lamp technique to illuminate and magnify the anterior segment of the eye, enabling detailed visualization of structures such as the cornea, iris, lens, and anterior chamber for diagnostic purposes.
The Slit Lamp BO 900, BQ 900, and BP900 are supplied as ac-powered medical devices and are classified as Class II under FDA regulations. They are intended for use in clinical settings, including ophthalmology offices and hospitals, and are authorized under FDA 510K and MDR compliance. The devices are not specified as single-use or reusable, and no MRI safety information is provided in the data.
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 (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K100202 | Class II | Active |
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Manufacturer
- Manufacturer
- Haag-Streit AG
Sources (2)
- FDA 510(k) K100202 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026