IOLMaster 500

Basic Information

• Brand Name: IOLMaster 500
• Primary DI: 04049471092066
• Version / Model: IOLMaster 500
• Company Name: Carl Zeiss Meditec AG
• Labeler DUNS: 314594680
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-18
• Public Version: 5
• Public Version Date: 2020-11-09
• Public Version Status: Update
• Public Device Record Key: 425adeb8-2247-4540-ae7b-34689590357b

Device Description

The IOLMaster is intended for the biometric determination of ocular measurements for axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	886.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48064	Optical low coherence reflectometry (OLCR) biometer	A mains electricity (AC-powered) ophthalmic device (a biometer) designed to determine the axial dimensions and frontal section of the eye including other biometric parameters/evaluations such as keratometry, white-to-white distance, pupillometry and consequently corneal power based on optical low coherence reflectometry (OLCR), non contact, measurement methods using light markers and digital image processing. It is normally adjustable on a cross stage with an integral chin rest and used to obtain measurements directly from the eye for processing and display via software, e.g., in an attached computer. Patient intraocular lens (IOL) suitability may also be calculated using different formulae.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049471092066	GS1

Premarket Submissions

Submission Number	Supplement Number
K122418	000
K141068	000

Device Sizes

Type	Value	Unit	Text
Weight	18	Kilogram
Device Size Text, specify			Height: max. 610 mm (2ft) (head rest)
Device Size Text, specify			Dimensions (footprint): 390 mm x 300 mm (1.28 ft x 0.98 ft)

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius