Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K042742 FDA 510(k)
- FDA Product Code
- MXK 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 Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM) is a confocal laser scanning microscope used for imaging the anterior segment of the eye. It utilizes a 670 nm Class I diode laser to scan the cornea, with light reflected or backscattered from the cornea detected via a confocal optical arrangement.
The device is supplied as a non-sterile, reusable system intended for use in ophthalmic clinical settings. It requires no specific sterility conditions and is not designated as single-use. Storage and handling should follow manufacturer guidelines, and the device operates under FDA 510(k) clearance (K042742) as a Class II medical 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: Heidelberg Retina Tomograph Ii / Rostock Cornea Module (Hrt Ii / Rcm ..., The perfect Image | Heidelberg Engineering GmbH, Heidelberg Retina Tomograph 2 HRT II For Sale - Nava Ophthalmic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042742 | Class II | Active |
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Manufacturer
- Manufacturer
- Heidelberg Engineering
Sources (1)
- FDA 510(k) K042742 24 fields · synced Sep 22, 2026