Cleared Traditional

CUSTOM ARTIFICIAL HUMAN EYES (K945270) - FDA 510(k) Clearance

Class I Ophthalmic device.

K945270 · Daniel T Acosta · Ophthalmic device
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May 1995
Decision
214d
Days
Class 1
Risk

K945270 is an FDA 510(k) clearance for the CUSTOM ARTIFICIAL HUMAN EYES. Classified as Eye, Artificial, Non-custom (product code HQH), Class I - General Controls.

Submitted by Daniel T Acosta (San Diego, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 214 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3200 - 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 Daniel T Acosta devices

Submission Details

510(k) Number K945270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1994
Decision Date May 30, 1995
Days to Decision 214 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 110d · This submission: 214d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQH Eye, Artificial, Non-custom
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.3200
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.