OUM · Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
Ophthalmic · 21 CFR 886.1050 · Class 1
Overview
| Product Code | OUM |
|---|---|
| Device Name | Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation |
| Regulation | 21 CFR 886.1050 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An adaptometer (biophotometer) is an AC-powered device that provides a stimulating light source which has various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K100954 | ADAPT, MODEL AX-03SN | Apeliotus Vision Science, Inc. | Feb 25, 2011 | SESE |
Top Applicants
- Apeliotus Vision Science, Inc. — 1 clearance
