Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5420](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5420) → KYE — Inserter/Remover Contact Lens

# KYE · Inserter/Remover Contact Lens

_Ophthalmic · 21 CFR 886.5420 · Class 1_

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

## Overview

- **Product Code:** KYE
- **Device Name:** Inserter/Remover Contact Lens
- **Regulation:** [21 CFR 886.5420](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5420)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.

## 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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K872567](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/KYE/K872567.md) | SOFT CONTACT LENS REMOVER | Magnivision, Inc. | Aug 10, 1987 | SESE |
| [K872591](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/KYE/K872591.md) | HARD CONTACT LENS REMOVER. ITEM #289 | Magnivision, Inc. | Aug 4, 1987 | SESE |
| [K871130](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/KYE/K871130.md) | CONTACT LENS TWEEZERS | S. M. C. Medi-Tech Corp. | May 12, 1987 | SESE |
| [K870072](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/KYE/K870072.md) | SUMMIT OPTICS CONTACT LENS REMOVER | Dayton Mfg. Co. | Feb 12, 1987 | SESE |
| [K850984](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/KYE/K850984.md) | MARLIN SOFT LENS HANDLER | Marlin Industries | Sep 10, 1985 | SESE |
| [K850983](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/KYE/K850983.md) | MARLIN SOFT LENS TWEEZER | Marlin Industries | Sep 10, 1985 | SESE |
| [K830738](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/KYE/K830738.md) | LENSERT CONTACT LENS CLEANING & INSERT | Jermyn Specialties of California | Jun 10, 1983 | SESE |
| [K830496](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/KYE/K830496.md) | DMV ANGLER | Dmv Contact Lens Co. | Mar 9, 1983 | SESE |
| [K782140](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/KYE/K782140.md) | REMOVER, SOFT-SERT CONTACT LENS | Mcmurray and Pendergost | Feb 12, 1979 | SESE |
| [K780931](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/KYE/K780931.md) | SOFT LENS INSERTER | Soft-Sert | Jun 28, 1978 | SESE |
| [K780664](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/KYE/K780664.md) | SOFT LENS REMOVER/INSERTER/MANIPULATOR | Dmv Contact Lens Co. | May 17, 1978 | SESE |
| [K780663](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/KYE/K780663.md) | CONTACT LENS REMOVER AND INSERTER | Dmv Contact Lens Co. | May 17, 1978 | SESE |

## Top Applicants

- Dmv Contact Lens Co. — 3 clearances
- Magnivision, Inc. — 2 clearances
- Marlin Industries — 2 clearances
- Dayton Mfg. Co. — 1 clearance
- Jermyn Specialties of California — 1 clearance

---

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

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