Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1050](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1050) → HJW — Adaptometer (Biophotometer)

# HJW · Adaptometer (Biophotometer)

_Ophthalmic · 21 CFR 886.1050 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJW

## Overview

- **Product Code:** HJW
- **Device Name:** Adaptometer (Biophotometer)
- **Regulation:** [21 CFR 886.1050](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1050)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJW](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJW)

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