Cleared Traditional

K170470 - Digital Eye Anterior Camera

K170470 is an FDA 510(k) clearance for Digital Eye Anterior Camera, manufactured by Medimaging Integrated Solution, Inc (Miis). The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K170470 · Medimaging Integrated Solution, Inc (Miis) · Ophthalmic device
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Oct 2017
Decision
232d
Days
Class 2
Risk

K170470 is an FDA 510(k) clearance for the Digital Eye Anterior Camera. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Medimaging Integrated Solution, Inc (Miis) (Hsinchu, TW). The FDA issued a Cleared decision on October 6, 2017 after a review of 232 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 Medimaging Integrated Solution, Inc (Miis) devices

FDA 510(k) Submission Details - K170470

510(k) Number K170470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2017
Decision Date October 06, 2017
Days to Decision 232 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 110d · This submission: 232d
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 31
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K170470.
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
IOLMaster 700
K173771 · Carl Zeiss Meditec, AG · Aug 2018
SL 220
K162684 · Carl Zeiss Meditec, AG · May 2017
IOLMaster 700
K170171 · Carl Zeiss Meditec, AG · Apr 2017
VISULUX
K161607 · Carl Zeiss Meditec, AG · Feb 2017