Cleared Traditional

K063310 - TRUEFIELD ANALYZER

K063310 is an FDA 510(k) clearance for TRUEFIELD ANALYZER, manufactured by Seeing Machines Limited. The device is a Class 1 Ophthalmic device with product code HPT cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K063310 · Seeing Machines Limited · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
273d
Days
Class 1
Risk

K063310 is an FDA 510(k) clearance for the TRUEFIELD ANALYZER. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Seeing Machines Limited (San Diego, US). The FDA issued a Cleared decision on August 2, 2007 after a review of 273 days - an extended review 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: 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 Seeing Machines Limited devices

FDA 510(k) Submission Details - K063310

510(k) Number K063310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2006
Decision Date August 02, 2007
Days to Decision 273 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
163d slower than avg
Panel avg: 110d · This submission: 273d
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 9
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K063310.
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