Cleared Traditional

ADAPT, MODEL AX-03SN (K100954) - FDA 510(k) Clearance

Class I Ophthalmic device.

K100954 · Apeliotus Vision Science, Inc. · Ophthalmic device
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Feb 2011
Decision
324d
Days
Class 1
Risk

K100954 is an FDA 510(k) clearance for the ADAPT, MODEL AX-03SN. Classified as Adaptometer (biophotometer), Software-based Data Acquisition And Stimulus Generation (product code OUM), Class I - General Controls.

Submitted by Apeliotus Vision Science, Inc. (Atlanta, US). The FDA issued a Cleared decision on February 25, 2011 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1050 - 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. Elevated predicate reliance profile. 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 Apeliotus Vision Science, Inc. devices

Submission Details

510(k) Number K100954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2010
Decision Date February 25, 2011
Days to Decision 324 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
214d slower than avg
Panel avg: 110d · This submission: 324d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OUM Adaptometer (biophotometer), Software-based Data Acquisition And Stimulus Generation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1050
Definition Measurement Of Retinal Adaptation (regeneration Of The Visual Purple) And Absolute Visible Sensitivity To Light.
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.