Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
The Adaptometer (Biophotometer), Software-Based Data Acquisition and Stimulus Generation (product code OUM) is an ophthalmic instrument used for measurement of retinal adaptation (regeneration of visual purple) and absolute visible sensitivity to light. It uses software-based data acquisition and stimulus generation to conduct dark adaptation testing, which is useful in evaluating retinal function. As an FDA Class 1 device under regulation 886.1050, it is subject only to general controls and falls within the Ophthalmic specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OUM
- Device Class
- FDA class 1
- Regulation Number
- 886.1050
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
Definition
Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K100954 | ADAPT, MODEL AX-03SN | Feb 25, 2011 | Substantially Equivalent | Apeliotus Vision Science, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.