Identifiers
- 510(k) Number
- K170171 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 700 is an optical biometry device designed for precise measurement of ocular parameters. It falls under the category of slit-lamp biomicroscopes and is used to assess key metrics such as axial length, corneal curvature, anterior chamber depth, and white-to-white corneal diameter. These measurements are critical for intraocular lens (IOL) calculations in cataract surgery planning, ensuring accurate lens power selection and optimal visual outcomes.
The IOLMaster 700 is a reusable, non-sterile device intended for use in clinical ophthalmic settings. It operates using optical coherence principles to capture high-resolution images of the eye without contact, minimizing patient discomfort. The device requires AC power and is classified as a Class II medical device under FDA regulations, with a 510(k) clearance for ophthalmic applications. Proper calibration and maintenance are essential for consistent performance, and it should be stored in a clean, controlled environment as per manufacturer guidelines.
Frequently asked questions
What ocular parameters does the IOLMaster 700 measure for cataract surgery planning?
The IOLMaster 700 measures critical ocular parameters such as axial length, corneal curvature, anterior chamber depth, and white-to-white corneal diameter. These measurements are essential for calculating intraocular lens (IOL) power, ensuring the selected lens matches the patient’s eye anatomy for optimal visual results after cataract surgery. The device uses optical coherence principles to capture high-resolution images without direct contact, reducing patient discomfort.
Is the IOLMaster 700 a single-use or reusable device?
The IOLMaster 700 is a reusable, non-sterile device designed for clinical ophthalmic use. Since it is intended for repeated use across multiple patients, proper cleaning, calibration, and maintenance are required to ensure accuracy and prevent cross-contamination. The manufacturer provides guidelines for storage in a clean, controlled environment to maintain performance.
What power source does the IOLMaster 700 require?
The IOLMaster 700 operates using AC power, meaning it must be connected to a standard electrical outlet to function. This requirement ensures consistent performance during clinical use, as fluctuations in power could affect measurement precision. Clinicians should verify the device’s power connection and stability before each use.
How should the IOLMaster 700 be stored to maintain its functionality?
The IOLMaster 700 should be stored in a clean, controlled environment to protect it from dust, moisture, and temperature extremes. Since it is reusable and non-sterile, it should not be exposed to conditions that could compromise its optical components or calibration. Follow the manufacturer’s instructions for storage to preserve accuracy and longevity.
What regulatory pathway does the IOLMaster 700 follow for FDA clearance?
The IOLMaster 700 received FDA clearance through a 510(k) submission, demonstrating that it is substantially equivalent to a legally marketed predicate device. The device is classified as a Class II medical device under FDA regulations, indicating it poses moderate risk and requires pre-market notification. The clearance was granted under the Ophthalmic advisory committee, reflecting its use in precision ocular measurements for surgical planning.
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 700: Outcomes you can trust, ZEISS IOLMaster 700, ZEISS IOLMASTER USER MANUAL Pdf Download | ManualsLib, PDF ZEISS IOLMaster 700
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170171 | Class II | Active |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
- FDA Applicant
- Carl Zeiss Meditec, AG
Sources (1)
- FDA 510(k) K170171 24 fields · synced Oct 5, 2026