FDA product code OUM: Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
OUM is the FDA product code for adaptometer (biophotometer), software-based data acquisition and stimulus generation. It is a Class I device, regulated under 21 CFR 886.1050 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under OUM. The average 510(k) review took 324 days (median 324).
Definition
Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.
Classification
| Field | Value |
|---|---|
| Device name | Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation |
| Device class | Class I |
| Regulation | 21 CFR 886.1050 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OUM clearance
Top OUM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Apeliotus Vision Science, Inc. | 1 | 2011-02-25 |
Most recent OUM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100954 | Apeliotus Vision Science, Inc. | ADAPT, MODEL AX-03SN | 2011-02-25 | 324 |
Recalls for OUM devices
openFDA lists no recalls for product code OUM.
Frequently asked questions
What is FDA product code OUM?
OUM is the FDA product code for adaptometer (biophotometer), software-based data acquisition and stimulus generation. It is a Class I device, regulated under 21 CFR 886.1050 and reviewed by the Ophthalmic panel.
What device class is OUM?
Class I, regulation 21 CFR 886.1050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OUM?
Across 1 cleared submissions the average was 324 days from receipt to decision (median 324).
Which companies have the most OUM clearances?
Apeliotus Vision Science, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OUM
- Run a recall and safety report across every OUM manufacturer
- Watch product code OUM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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