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) → HPY — Unit, Electrolysis, Battery-Powered, Ophthalmic

# HPY · Unit, Electrolysis, Battery-Powered, Ophthalmic

_Ophthalmic · 21 CFR 886.4250 · Class 1_

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

## Overview

- **Product Code:** HPY
- **Device Name:** Unit, Electrolysis, Battery-Powered, Ophthalmic
- **Regulation:** [21 CFR 886.4250](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4250)
- **Device Class:** 1
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K903666](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPY/K903666.md) | OPHTHASONIC A/P III | Teknar, Inc. | Nov 19, 1990 | SESE |

## Top Applicants

- Teknar, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPY](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPY)

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