Cleared Traditional

K170171 - IOLMaster 700

K170171 is an FDA 510(k) clearance for IOLMaster 700, 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 77-day FDA review.

K170171 · Carl Zeiss Meditec, AG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
77d
Days
Class 2
Risk

K170171 is an FDA 510(k) clearance for the IOLMaster 700. 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 April 6, 2017 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Carl Zeiss Meditec, AG devices

FDA 510(k) Submission Details - K170171

510(k) Number K170171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2017
Decision Date April 06, 2017
Days to Decision 77 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
33d faster than avg
Panel avg: 110d · This submission: 77d
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 Consultant

Biologics Consulting Group, Inc.
Rahul Ram

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K170171.
IOLMaster 700
K173771 · Carl Zeiss Meditec, AG · Aug 2018
SL 220
K162684 · Carl Zeiss Meditec, AG · May 2017
SLIT LAMP SL-2000
K163564 · Nidek Co., Ltd. · May 2017
VISULUX
K161607 · Carl Zeiss Meditec, AG · Feb 2017
IOLMaster700
K143275 · Carl Zeiss Meditec, Inc. · Jul 2015
ZEISS CATARACT SUITE MARKERLESS
K141068 · Carl Zeiss Meditec, AG · Sep 2014