Cleared Traditional

K142877 - EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)

K142877 is an FDA 510(k) clearance for EVA, manufactured by Dutch Ophthalmic Research Center International BV. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K142877 · Dutch Ophthalmic Research Center International BV · Ophthalmic device
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Mar 2015
Decision
163d
Days
Class 2
Risk

K142877 is an FDA 510(k) clearance for the EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(.... Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Dutch Ophthalmic Research Center International BV (Zuidland, NL). The FDA issued a Cleared decision on March 13, 2015 after a review of 163 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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 Dutch Ophthalmic Research Center International BV devices

FDA 510(k) Submission Details - K142877

510(k) Number K142877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2014
Decision Date March 13, 2015
Days to Decision 163 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
53d slower than avg
Panel avg: 110d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 193
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