Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1425](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1425) → HLM — Instrument, Measuring, Lens, Ac-Powered

# HLM · Instrument, Measuring, Lens, Ac-Powered

_Ophthalmic · 21 CFR 886.1425 · Class 1_

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

## Overview

- **Product Code:** HLM
- **Device Name:** Instrument, Measuring, Lens, Ac-Powered
- **Regulation:** [21 CFR 886.1425](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1425)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A lens measuring instrument is an AC-powered device intended to measure the power of lenses, prisms, and their centers (e.g., lensometer).

## 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 (16 of 16)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K944022](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K944022.md) | LENSCHEK | Leica, Inc. | Nov 17, 1994 | SESE |
| [K940997](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K940997.md) | AL-3300 | Hoya Corp. USA | Sep 29, 1994 | SESE |
| [K936199](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K936199.md) | AUTOMATIC LENSOMETER | Canon USA, Inc. | Sep 28, 1994 | SESE |
| [K930441](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K930441.md) | MARCO STANDARD LENSMETERS 101,201 | Marco Ophthalmic, Inc. | Jul 6, 1993 | SESE |
| [K930445](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K930445.md) | MARCO LM-770 DIGITAL PROJECTION LENSMETER | Marco Ophthalmic, Inc. | Jun 21, 1993 | SESE |
| [K924788](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K924788.md) | BURTON LENSMETER | R.H. Burton Co. | Apr 5, 1993 | SESE |
| [K924785](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K924785.md) | BURTON RADIUSGAUGE - MODEL 2030 | R.H. Burton Co. | Apr 5, 1993 | SESE |
| [K924776](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K924776.md) | BURTON LENSMETER - MODEL 2021 | R.H. Burton Co. | Apr 5, 1993 | SESE |
| [K920861](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K920861.md) | WOODLYN CLASSIC LENSMETER | Woodlyn, Inc. | Jul 30, 1992 | SESE |
| [K884188](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K884188.md) | NIDEK LM-870 AUTOMATIC LENSMETER | Nidek, Inc. | Nov 23, 1988 | SESE |
| [K862518](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K862518.md) | BAUSCH & LOMB VERTOMETER V-5 | Bausch & Lomb, Inc. | Aug 11, 1986 | SESE |
| [K861064](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K861064.md) | LM-850 AUTOMATIC LENSMETER | Nidek, Inc. | Apr 15, 1986 | SESE |
| [K801767](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K801767.md) | DIMENSION I REFRACTION SYSTEM | Smr | Sep 16, 1980 | SESE |
| [K791521](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K791521.md) | VERI-VU LENSOMETER | Intermedics, Inc. | Oct 30, 1979 | SESE |
| [K782096](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K782096.md) | INSTRUMENTS, OVERREFRACTION SYSTEM | Zeiss Humphrey System | Jan 26, 1979 | SESE |
| [K781440](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K781440.md) | LENSOMETER MODEL 11 | Rodenstock Instrument Corp. | Sep 7, 1978 | SESE |

## Top Applicants

- R.H. Burton Co. — 3 clearances
- Marco Ophthalmic, Inc. — 2 clearances
- Nidek, Inc. — 2 clearances
- Bausch & Lomb, Inc. — 1 clearance
- Canon USA, Inc. — 1 clearance

---

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

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