Identifiers
- 510(k) Number
- K082891 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 Lenstar Model LS900 is an optical biometry device designed for precise measurement of ocular biometry, including axial length, corneal curvature, and anterior chamber depth. It integrates optical coherence tomography (OCT) and Scheimpflug imaging to provide detailed axial length measurements, supporting preoperative planning for cataract surgery and refractive procedures. This device is classified as a biomicroscope, slit-lamp, AC-powered system and is specifically engineered for ophthalmic applications.
The Lenstar Model LS900 is supplied as a reusable medical device intended for use in clinical ophthalmology settings. It operates on AC power and is not intended for MRI environments, as it contains non-MRI-compatible components. The device requires proper calibration and maintenance in accordance with manufacturer guidelines, and its use is governed by FDA 510(k) clearance (K082891) and compliance with the Medical Device Directive (MDD). Storage and handling follow standard sterile or non-sterile medical device protocols, depending on the specific clinical procedure.
Frequently asked questions
What clinical applications is the Lenstar LS900 primarily used for in ophthalmology?
The Lenstar LS900 is designed for precise ocular biometry measurements, including axial length, corneal curvature, and anterior chamber depth. These measurements are critical for preoperative planning in cataract surgery and refractive procedures, such as IOL (intraocular lens) power calculations and corneal surgery. Its integration of OCT and Scheimpflug imaging ensures detailed axial length assessment, which supports accurate surgical planning.
Is the Lenstar LS900 a single-use or reusable device, and what are the storage requirements?
The Lenstar LS900 is a reusable medical device intended for clinical ophthalmology settings. Since it is not sterile by design, storage follows standard non-sterile medical device protocols. Proper calibration and maintenance are required as per the manufacturer’s guidelines to ensure accuracy and reliability. It should be stored in a clean, dry environment, protected from dust and moisture, and handled according to best practices for reusable medical equipment.
Can the Lenstar LS900 be used in an MRI environment, and why?
No, the Lenstar LS900 is not intended for use in MRI environments. The device contains non-MRI-compatible components, which could pose safety risks or interfere with MRI functionality if exposed to magnetic fields. Always ensure the device is used in non-MRI areas to avoid potential hazards.
What regulatory pathways does the Lenstar LS900 follow, and how does this affect its use?
The Lenstar LS900 follows FDA 510(k) clearance (K082891) and complies with the Medical Device Directive (MDD). This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device and meets EU safety and performance standards. Clinicians and facilities should ensure compliance with these regulatory requirements, including proper training, maintenance, and adherence to manufacturer instructions for use.
What power source does the Lenstar LS900 require, and are there any environmental considerations?
The Lenstar LS900 operates on AC power, meaning it must be connected to a standard electrical outlet for functionality. Environmental considerations include avoiding use in areas with strong electromagnetic interference, as well as ensuring the device is not exposed to extreme temperatures or humidity. The manufacturer’s guidelines should be followed for optimal performance and longevity.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K082891 | Class II | Active |
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Manufacturer
- Manufacturer
- Haag-Streit AG
Sources (2)
- FDA 510(k) K082891 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026