HLM · Instrument, Measuring, Lens, Ac-Powered
Ophthalmic · 21 CFR 886.1425 · Class 1
Overview
| Product Code | HLM |
|---|---|
| Device Name | Instrument, Measuring, Lens, Ac-Powered |
| Regulation | 21 CFR 886.1425 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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 | LENSCHEK | Leica, Inc. | Nov 17, 1994 | SESE |
| K940997 | AL-3300 | Hoya Corp. USA | Sep 29, 1994 | SESE |
| K936199 | AUTOMATIC LENSOMETER | Canon USA, Inc. | Sep 28, 1994 | SESE |
| K930441 | MARCO STANDARD LENSMETERS 101,201 | Marco Ophthalmic, Inc. | Jul 6, 1993 | SESE |
| K930445 | MARCO LM-770 DIGITAL PROJECTION LENSMETER | Marco Ophthalmic, Inc. | Jun 21, 1993 | SESE |
| K924788 | BURTON LENSMETER | R.H. Burton Co. | Apr 5, 1993 | SESE |
| K924785 | BURTON RADIUSGAUGE - MODEL 2030 | R.H. Burton Co. | Apr 5, 1993 | SESE |
| K924776 | BURTON LENSMETER - MODEL 2021 | R.H. Burton Co. | Apr 5, 1993 | SESE |
| K920861 | WOODLYN CLASSIC LENSMETER | Woodlyn, Inc. | Jul 30, 1992 | SESE |
| K884188 | NIDEK LM-870 AUTOMATIC LENSMETER | Nidek, Inc. | Nov 23, 1988 | SESE |
| K862518 | BAUSCH & LOMB VERTOMETER V-5 | Bausch & Lomb, Inc. | Aug 11, 1986 | SESE |
| K861064 | LM-850 AUTOMATIC LENSMETER | Nidek, Inc. | Apr 15, 1986 | SESE |
| K801767 | DIMENSION I REFRACTION SYSTEM | Smr | Sep 16, 1980 | SESE |
| K791521 | VERI-VU LENSOMETER | Intermedics, Inc. | Oct 30, 1979 | SESE |
| K782096 | INSTRUMENTS, OVERREFRACTION SYSTEM | Zeiss Humphrey System | Jan 26, 1979 | SESE |
| K781440 | 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
