Cleared Traditional

K923543 - MIS

K923543 is an FDA 510(k) clearance for MIS, manufactured by Ceram Optec, Inc.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K923543

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.

HLJ Device Classification - Class 2, Special Controls

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 33
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