Cleared Traditional

K023719 - MP-1 MICRO PERIMETER

K023719 is an FDA 510(k) clearance for MP-1 MICRO PERIMETER, manufactured by Nidek Technologies Srl. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K023719 · Nidek Technologies Srl · Ophthalmic device
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Dec 2002
Decision
48d
Days
Class 2
Risk

K023719 is an FDA 510(k) clearance for the MP-1 MICRO PERIMETER. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Nidek Technologies Srl (Vigonza (Padova), IT). The FDA issued a Cleared decision on December 23, 2002 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nidek Technologies Srl devices

FDA 510(k) Submission Details - K023719

510(k) Number K023719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2002
Decision Date December 23, 2002
Days to Decision 48 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 110d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 - HKI Camera, Ophthalmic, Ac-powered

All 75
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K023719.
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NIDEK HANDY
K973218 · Nidek, Inc. · Nov 1997