510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100954Substantially Equivalent

Adapt, Model Ax-03Sn

Apeliotus Vision Science, Inc., Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100954 is the FDA 510(k) clearance record for ADAPT, MODEL AX-03SN, a class I device, cleared for Apeliotus Vision Science, Inc. on under FDA product code OUM (Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation). FDA's definition for product code OUM reads: "Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light". FDA records list one 510(k) clearance for Apeliotus Vision Science, Inc. As of , FDA records show no recalls naming K100954.

Clearance record

Decision date
Received
(324 days to decision)
Product code
OUM Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
Regulation
21 CFR 886.1050
Device class
Class I
Review panel
Ophthalmic
Applicant
Apeliotus Vision Science, Inc. 1456 N. Morningside Dr. NE, Atlanta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUM

Trailing 12 months

FDA records hold no clearances under product code OUM in the trailing twelve months.

FDA records show no clearances under product code OUM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OUM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260