Rodenstock Scanning Laser Ophthalmoscope

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K871268 ↗

FDA Product Code

HLI

Device Class

Class II

Regulation

21 CFR Part 886.1570

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Orion 3001, Laser Photocoagulator

  Class II

  FDA 510(k) K864063 Active Cleared 13 Nov 1986

• Rodenstock Laser Slitlamp

  Class II

  FDA 510(k) K973220 Active Cleared 4 Nov 1997

• What is the primary clinical purpose of the Rodenstock Scanning Laser Ophthalmoscope, and how does it differ from traditional ophthalmoscopes?

  The Rodenstock Scanning Laser Ophthalmoscope is designed to capture high-resolution images of the retina using laser technology, enabling detailed visualization of the fundus oculi for clinical assessment. Unlike traditional ophthalmoscopes, which rely on direct or indirect light reflection for visualization, this device uses scanning laser technology to provide enhanced imaging clarity, making it particularly useful for diagnosing retinal conditions in ophthalmic settings.

• Is the Rodenstock Scanning Laser Ophthalmoscope intended for single-use or reusable applications, and what does this mean for maintenance?

  The Rodenstock Scanning Laser Ophthalmoscope is explicitly supplied as a reusable medical instrument. This means it is designed for repeated use across multiple patients, provided it undergoes proper cleaning, disinfection, and maintenance between procedures. Reusability requires adherence to facility protocols for sterilization or high-level disinfection to ensure safety and functionality.

• What regulatory pathway was followed for FDA clearance of this device, and what does the product code (HLI) signify?

  The Rodenstock Scanning Laser Ophthalmoscope received FDA clearance through a 510(k) submission (K871268) under the Traditional Review pathway, classified as Class II with the product code HLI (Hearing, Vision, Speech, and Balance Devices). The HLI code indicates its primary use in ophthalmic diagnostics, specifically for imaging the retina, rather than defining a clinical indication.

• Does the device require third-party sterility testing, and what storage or handling considerations should be noted?

  The regulatory data does not specify third-party sterility requirements for this device, meaning sterility is not a mandatory pre-market requirement. However, since it is reusable, proper storage and handling—such as cleaning, disinfection, and calibration—are critical to maintain performance and prevent cross-contamination. Follow manufacturer guidelines for maintenance and environmental conditions.

• Are there multiple models or variations of this device, and how can I verify compatibility with my practice’s needs?

  The device data lists multiple FEI numbers (e.g., 3009685433, 1000391004), which may correspond to different models or configurations supplied by the manufacturer. While these identifiers are tied to regulatory filings, they do not explicitly describe functional variations. To confirm compatibility, consult the manufacturer’s technical specifications or contact G. Rodenstock Instrumente GmbH directly, referencing the exact FEI or model number in use.