Cleared Traditional

K131939 - AMICO DH-W35 OPHTHALMOSCOPE SERIES

K131939 is an FDA 510(k) clearance for AMICO DH-W35 OPHTHALMOSCOPE SERIES, manufactured by Amico Diagnostic Incorporated. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K131939 · Amico Diagnostic Incorporated · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
272d
Days
Class 2
Risk

K131939 is an FDA 510(k) clearance for the AMICO DH-W35 OPHTHALMOSCOPE SERIES. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Amico Diagnostic Incorporated (Apollo Beach, US). The FDA issued a Cleared decision on March 26, 2014 after a review of 272 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.

FDA 510(k) Submission Details - K131939

510(k) Number K131939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2013
Decision Date March 26, 2014
Days to Decision 272 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
162d slower than avg
Panel avg: 110d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLI Device Classification - Class 2, Special Controls

Product Code HLI Ophthalmoscope, Ac-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 - HLI Ophthalmoscope, Ac-powered

All 84
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K131939.
OCT-Camera
K142953 · Optomedical Technologies GmbH · Mar 2015
PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
K141638 · Propper Manufacturing Co., Inc. · Sep 2014
CENTERVUE MACULAR INTEGRITY ASSESSMENT
K133758 · Centervue S.P.A. · Apr 2014
IVUE 500
K133892 · Optovue, Inc. · Mar 2014
HEINE OMEGA 500
K123316 · Heine Optotechnik GmbH & Co. KG · Feb 2013
IVUE WITH NORMATIVE DATABASE
K121739 · Optovue, Inc. · Jan 2013
K131939 · AMICO DH-W35 OPHTHALMOSCOPE SERIES
Download PDF FDA Summary Amico Diagnostic Inco…