Cleared Traditional

TRUEFIELD ANALYZER (K063310) - FDA 510(k) Clearance

Class I Ophthalmic device.

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

Submission Details

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.

Device Classification

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.