Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4250](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4250) → HRO — Unit, Electrolysis, Ac-Powered, Ophthalmic

# HRO · Unit, Electrolysis, Ac-Powered, Ophthalmic

_Ophthalmic · 21 CFR 886.4250 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRO

## Overview

- **Product Code:** HRO
- **Device Name:** Unit, Electrolysis, Ac-Powered, Ophthalmic
- **Regulation:** [21 CFR 886.4250](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4250)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy ocular hair follicles by applying a galvanic electrical current.

## Classification Rationale

(1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Special Controls

*Classification.* (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered 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-e%E2%80%94surgical-devices/HRO](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRO)

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