Identifiers
- 510(k) Number
- K122418 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 IOLMaster 500 is an AC-powered biomicroscope and slit-lamp device used for optical biometry. It is designed to perform measurements for intraocular lens power calculations.
This device has received FDA 510(k) clearance under the ophthalmic medical specialty. It is intended for clinical use by cataract surgeons.
Frequently asked questions
What is the primary clinical use of the IOLMaster 500?
The IOLMaster 500 is an AC-powered biomicroscope and slit-lamp device intended for optical biometry. It is specifically designed to perform the measurements required for calculating intraocular lens power, supporting cataract surgeons in their clinical practice.
What is the regulatory status of this device?
The IOLMaster 500 has received FDA 510(k) clearance under the ophthalmic medical specialty. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the same category.
Who is the manufacturer of the IOLMaster 500?
The IOLMaster 500 is manufactured by Carl Zeiss Meditec AG, located in Dublin, California. The device is categorized under the ophthalmic medical specialty and is designed for use by cataract surgeons.
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: ZEISS IOLMaster 500 - optical biometry, ZEISS Optical Biometers - 150 million power calculations to date, ZEISS IOLMASTER 500 MANUAL Pdf Download | ManualsLib, PDF ZEISS IOLMaster 500 - Next Vision Instruments
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122418 | Class II | Active |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
- FDA Applicant
- Carl Zeiss Meditec, AG
Sources (1)
- FDA 510(k) K122418 24 fields · synced Oct 6, 2026