AL-2000 Combined Biometer and Pachymeter
FDA 510(k)Class II (US FDA 510(k))
by Tomey Corp.
Identifiers
- 510(k) Number
- K012803 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AL-2000 Combined Biometer and Pachymeter is an ultrasound-based device classified as a biometer and corneal pachymeter. It measures the axial length of the eye and corneal thickness, supporting intraocular lens (IOL) power calculations for implanted lenses.
This device is supplied as a reusable medical instrument and is intended for use in ophthalmic settings. It requires FDA 510(k) clearance (K012803) and is regulated under the Radiology advisory committee. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What types of measurements does the AL-2000 device perform, and how are these used in clinical practice?
The AL-2000 is designed to measure two key eye parameters: axial length (the distance from the cornea to the retina) and corneal thickness. These measurements are critical for calculating the power of intraocular lenses (IOLs) during cataract surgery, ensuring accurate lens placement for optimal vision correction. The ultrasound-based technology provides precise data to guide surgical planning.
Is the AL-2000 device single-use or reusable, and what does this mean for maintenance and cleaning?
The AL-2000 is explicitly labeled as a reusable medical instrument. Since it is not sterile out-of-the-box, it must be thoroughly cleaned and maintained between uses in an ophthalmic setting. Reusability implies the device requires proper disinfection and sterilization protocols to prevent cross-contamination, though specific cleaning instructions are not detailed in the provided data.
How is the AL-2000 device regulated, and which advisory committee oversees its classification?
The AL-2000 is regulated under the Radiology advisory committee (RA) and holds an FDA 510(k) clearance (K012803). It was determined to be substantially equivalent to a predicate device, meaning its safety and performance were compared to an existing, legally marketed alternative. The device falls under product code IYO, which categorizes it within ophthalmic diagnostic imaging tools.
Does the AL-2000 device come with any specific storage or handling instructions?
The provided data does not include explicit storage or handling instructions for the AL-2000. However, as a reusable medical instrument, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality. Since it is not sterile, proper maintenance and cleaning protocols must be followed to ensure reliable 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. Sources consulted: TOMEY AL-2000 OPERATOR'S MANUAL Pdf Download | ManualsLib, Tomey AL-2000 Biometer & Pachymeter Operator Manual, Tomey AL-2000 Manuals | ManualsLib, AL-2000 COMBINED BIOMETER AND PACHYMETER (K012803) — FDA 510 (k ..., Tomey AL-2000 Biometer & Pachymeter - Combined Optical Diagnostic System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012803 | Class II | Active |
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Manufacturer
- Manufacturer
- Tomey Corp.
Sources (1)
- FDA 510(k) K012803 24 fields · synced Sep 19, 2026