Cleared Traditional

K100954 - ADAPT, MODEL AX-03SN

K100954 is an FDA 510(k) clearance for ADAPT, manufactured by Apeliotus Vision Science, Inc.. The device is a Class 1 Ophthalmic device with product code OUM cleared through the Traditional 510(k) pathway after a 324-day FDA review.

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

FDA 510(k) Submission Details - K100954

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.

OUM Device Classification - Class 1, General Controls

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.