510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QERClass II

Camera, Ophthalmic, Slit-Scanning

21 CFR 886.1120 / Ophthalmic
FDA source (opens on fda.gov)

QER is the FDA product code for Camera, Ophthalmic, Slit-Scanning, a class II device type, regulated under 21 CFR 886.1120. FDA's definition for this code reads: "An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QER
Device name
Camera, Ophthalmic, Slit-Scanning
FDA definition
An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Regulation
21 CFR 886.1120
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code QER

By decision year
3 clearances under product code QER with a decision year between 2019 and 2025, 2019 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QER by decision year
YearClearances
20192
20251

Applicants with the most clearances

Product code QER
Applicants holding the most 510(k) clearances under product code QER
ApplicantClearances
Carl Zeiss Meditec Inc3

Companies listing this code with FDA

Companies whose registered establishments list this code