Cleared Traditional

K161607 - VISULUX

K161607 is an FDA 510(k) clearance for VISULUX, manufactured by Carl Zeiss Meditec, AG. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K161607 · Carl Zeiss Meditec, AG · Ophthalmic device
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Feb 2017
Decision
258d
Days
Class 2
Risk

K161607 is an FDA 510(k) clearance for the VISULUX. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on February 23, 2017 after a review of 258 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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 Carl Zeiss Meditec, AG devices

FDA 510(k) Submission Details - K161607

510(k) Number K161607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2016
Decision Date February 23, 2017
Days to Decision 258 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
148d slower than avg
Panel avg: 110d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJO Device Classification - Class 2, Special Controls

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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 - HJO Biomicroscope, Slit-lamp, Ac-powered

All 47
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K161607.
SL 220
K162684 · Carl Zeiss Meditec, AG · May 2017
SLIT LAMP SL-2000
K163564 · Nidek Co., Ltd. · May 2017
IOLMaster 700
K170171 · Carl Zeiss Meditec, AG · Apr 2017
IOLMaster700
K143275 · Carl Zeiss Meditec, Inc. · Jul 2015
ZEISS CATARACT SUITE MARKERLESS
K141068 · Carl Zeiss Meditec, AG · Sep 2014
OPTICAL BIOMETER AL-SCAN
K133132 · Nidek Co., Ltd. · Jun 2014