Cleared Traditional

K173771 - IOLMaster 700

K173771 is the FDA 510(k) clearance for IOLMaster 700 by Carl Zeiss Meditec, AG. It is a Class 2 Ophthalmic device (product code HJO) cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K173771 · Carl Zeiss Meditec, AG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
256d
Days
Class 2
Risk

K173771 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 August 24, 2018 after a review of 256 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

Submission Details

510(k) Number K173771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2017
Decision Date August 24, 2018
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 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.
Lisa Graney

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 9
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K173771.
Kowa SL-19
K222372 · Kowa Company , Ltd. · Nov 2022
MiiS Horus Eye Anterior Camera
K193188 · Medimaging Integrated Solution, Inc (Miis) · Jan 2020
Sunkingdom Slit Lamp
K182306 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · Nov 2018
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873 · Bausch & Lomb, Inc. · Nov 2001
BAUSCH & LOMB CSL-1000 SLIT LAMP
K862515 · Bausch & Lomb, Inc. · Jul 1986
BAUSCH & LOMB OSL-2000 SLIT LAMP
K862516 · Bausch & Lomb, Inc. · Jul 1986