Cleared Traditional

K050350 - THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)

K050350 is an FDA 510(k) clearance for THE NOTAL VISION PREVIEW PREFERENTIAL H..., manufactured by Notal Vision, Inc.. The device is a Class 1 Ophthalmic device with product code HPT cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K050350 · Notal Vision, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
77d
Days
Class 1
Risk

K050350 is an FDA 510(k) clearance for the THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP). Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Notal Vision, Inc. (Rockville, US). The FDA issued a Cleared decision on April 29, 2005 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1605 - 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.

FDA 510(k) Submission Details - K050350

510(k) Number K050350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2005
Decision Date April 29, 2005
Days to Decision 77 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
33d faster than avg
Panel avg: 110d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

HPT Device Classification - Class 1, General Controls

Product Code HPT Perimeter, Automatic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HPT Perimeter, Automatic, Ac-powered

All 38
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K050350.
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K050350 · THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)
Download PDF FDA Summary Notal Vision, Inc.