Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5928](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5928) → HRC — Sterilizer, Soft-Lens, Thermal, Battery-Powered

# HRC · Sterilizer, Soft-Lens, Thermal, Battery-Powered

_Ophthalmic · 21 CFR 886.5928 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HRC

## Overview

- **Product Code:** HRC
- **Device Name:** Sterilizer, Soft-Lens, Thermal, Battery-Powered
- **Regulation:** [21 CFR 886.5928](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5928)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

## Classification Rationale

Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

## Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K920037](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HRC/K920037.md) | OSTEO COMPRESSION HIP SCREW | Osteo AG | Mar 11, 1992 | SESE |

## Top Applicants

- Osteo AG — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HRC](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HRC)

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