21 CFR 886.1050 — Adaptometer (Biophotometer)
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1050
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HJW | Adaptometer (Biophotometer) | 1 | 0 | |
| OUM | Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation | 1 | 1 | SaMD |
