Cleared Traditional

K131719 - OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS

K131719 is an FDA 510(k) clearance for OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS, manufactured by Medical Devices (Pvt) , Ltd.. The device is a Class 2 Ophthalmic device with product code HLJ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K131719 · Medical Devices (Pvt) , Ltd. · Ophthalmic device
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Oct 2013
Decision
140d
Days
Class 2
Risk

K131719 is an FDA 510(k) clearance for the OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Medical Devices (Pvt) , Ltd. (Ugoki-Sialkot, PK). The FDA issued a Cleared decision on October 30, 2013 after a review of 140 days - within the typical 510(k) review window.

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 - K131719

510(k) Number K131719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2013
Decision Date October 30, 2013
Days to Decision 140 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 110d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLJ Device Classification - Class 2, Special Controls

Product Code HLJ Ophthalmoscope, Battery-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 - HLJ Ophthalmoscope, Battery-powered

All 37
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K131719.
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K131719 · OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
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