Ophthalmic · 510(k) · 2025
CLARUS (700)
Carl Zeiss Meditec, Inc.. Cleared by FDA on 17 April 2025 under submission K243878, product code QER (camera, ophthalmic, slit-scanning). What FDA's record says, in FDA's words.
Device record · K243878
- Device. CLARUS (700)DEVICE
- Company. Carl Zeiss Meditec, Inc.COMPANY
- Decision. 17 April 2025, 510(k), substantially equivalent (traditional review); received 18 December 2024DECISION
- Panel. OphthalmicPANEL
- Product code. QER, Camera, Ophthalmic, Slit-ScanningCODE
- Regulation. 21 CFR 886.1120, Class IIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS 700 angiography is indicated as an aid in the vis This device is Prescription Use (Rx) only.
The product code's definition, from FDA's classification record. An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsa diagnostic claim
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QER. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QER, in Ophthalmic, from Carl Zeiss Meditec, Inc., or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.