HJW · Adaptometer (Biophotometer)
Ophthalmic · 21 CFR 886.1050 · Class 1
Overview
| Product Code | HJW |
|---|---|
| Device Name | Adaptometer (Biophotometer) |
| 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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
