Cleared Traditional

K923543 - MIS

K923543 is the FDA 510(k) clearance for MIS by Ceram Optec, Inc.. It is a Class 2 Ophthalmic device (product code HLJ) cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K923543 · Ceram Optec, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
256d
Days
Class 2
Risk

K923543 is an FDA 510(k) clearance for the MIS. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Ceram Optec, Inc. (Washington, US). The FDA issued a Cleared decision on March 29, 1993 after a review of 256 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ceram Optec, Inc. devices

Submission Details

510(k) Number K923543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1992
Decision Date March 29, 1993
Days to Decision 256 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 110d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HLJ Ophthalmoscope, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HLJ Ophthalmoscope, Battery-powered

All 18
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K923543.
UNI II
K925756 · Rudolf Riester GmbH & Co. KG · Oct 1993
RI-FORMER
K932504 · Rudolf Riester GmbH & Co. KG · Oct 1993
OPHTHALMOSCOPE
K925757 · Rudolf Riester GmbH & Co. KG · Aug 1993
INDIRECT OPHTHALMOSCOPE
K853891 · Carl Zeiss, Inc. · Oct 1985
MEDIC LUX DIAGNOSTIC SETS
K832437 · Keeler Instruments, Inc. · Aug 1983
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
K830215 · Jedmed Instrument Co. · Mar 1983