Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1405](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1405) → HPC — Set, Lens, Trial, Ophthalmic

# HPC · Set, Lens, Trial, Ophthalmic

_Ophthalmic · 21 CFR 886.1405 · Class 1_

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

## Overview

- **Product Code:** HPC
- **Device Name:** Set, Lens, Trial, Ophthalmic
- **Regulation:** [21 CFR 886.1405](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1405)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.

## 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 (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K945443](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K945443.md) | BOBES LENS SET | Bobes S.A. | Jul 19, 1995 | SESE |
| [K951437](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K951437.md) | OTI MODEL TLS-60 | Oti Medical, LLC | Apr 11, 1995 | SESE |
| [K930195](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K930195.md) | OPHTHALMIC TRIAL LENSES | Optimark Accessories and Instruments | Jan 6, 1994 | SESE |
| [K934859](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K934859.md) | CONTACT LENSES | Arno Intl., Inc. | Dec 21, 1993 | SESE |
| [K930446](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K930446.md) | MARCO TRIAL SETS | Marco Ophthalmic, Inc. | Jul 6, 1993 | SESE |
| [K924786](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K924786.md) | BURTON TRIAL LENS SET | R.H. Burton Co. | Apr 14, 1993 | SESE |
| [K920571](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K920571.md) | TRIAL LENS SET | R.H. Burton Co. | May 7, 1992 | SESE |
| [K900478](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K900478.md) | WOODLYN FULL APERTURE TRIAL LENS SET | Woodlyn, Inc. | Feb 21, 1990 | SESE |
| [K873907](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K873907.md) | CONFIRMATION TESTS | Richmond Products, Inc. | Dec 29, 1987 | SESE |
| [K852056](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K852056.md) | ACC CROSS CYLINDERS | Ascon Medical Instruments, Ltd. | Jun 5, 1985 | SESE |
| [K843095](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K843095.md) | TRIA LENS SET | Optek Medico Co., Ltd. | Oct 5, 1984 | SESE |
| [K841766](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K841766.md) | WOODLYN CLASSIC TRIAL LENS SET | Woodlyn, Inc. | Jun 1, 1984 | SESE |
| [K770389](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K770389.md) | LENS SET, MENTOR TRIAL | Codman & Shurtleff, Inc. | Mar 14, 1977 | SESE |

## Top Applicants

- R.H. Burton Co. — 2 clearances
- Woodlyn, Inc. — 2 clearances
- Arno Intl., Inc. — 1 clearance
- Ascon Medical Instruments, Ltd. — 1 clearance
- Bobes S.A. — 1 clearance

---

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

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