Instrument, Measuring, Lens, Ac-Powered
The AC-Powered Ophthalmic Lens Measuring Instrument is an electrically powered device, such as a lensometer or focimeter, used to measure the optical power and other properties of ophthalmic lenses including sphere, cylinder, axis, and prism. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without any premarket notification requirement. The product code is HLM, regulated under 21 CFR 886.1425, within the Ophthalmic medical specialty. No special risk flags apply to this device.
Research product code HLM in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HLM
- Device Class
- FDA class 1
- Regulation Number
- 886.1425
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944022 | LENSCHEK | Nov 17, 1994 | Substantially Equivalent | Leica, Inc. |
| K940997 | AL-3300 | Sep 29, 1994 | Substantially Equivalent | Hoya Corp. USA |
| K936199 | AUTOMATIC LENSOMETER | Sep 28, 1994 | Substantially Equivalent | Canon USA, Inc. |
| K930441 | MARCO STANDARD LENSMETERS 101,201 | Jul 06, 1993 | Substantially Equivalent | Marco Ophthalmic, Inc. |
| K930445 | MARCO LM-770 DIGITAL PROJECTION LENSMETER | Jun 21, 1993 | Substantially Equivalent | Marco Ophthalmic, Inc. |
| K924788 | BURTON LENSMETER | Apr 05, 1993 | Substantially Equivalent | R.H. Burton Co. |
| K924785 | BURTON RADIUSGAUGE - MODEL 2030 | Apr 05, 1993 | Substantially Equivalent | R.H. Burton Co. |
| K924776 | BURTON LENSMETER - MODEL 2021 | Apr 05, 1993 | Substantially Equivalent | R.H. Burton Co. |
| K920861 | WOODLYN CLASSIC LENSMETER | Jul 30, 1992 | Substantially Equivalent | Woodlyn, Inc. |
| K884188 | NIDEK LM-870 AUTOMATIC LENSMETER | Nov 23, 1988 | Substantially Equivalent | Nidek, Inc. |
| K862518 | BAUSCH & LOMB VERTOMETER V-5 | Aug 11, 1986 | Substantially Equivalent | Bausch & Lomb, Inc. |
| K861064 | LM-850 AUTOMATIC LENSMETER | Apr 15, 1986 | Substantially Equivalent | Nidek, Inc. |
| K801767 | DIMENSION I REFRACTION SYSTEM | Sep 16, 1980 | Substantially Equivalent | Smr |
| K791521 | VERI-VU LENSOMETER | Oct 30, 1979 | Substantially Equivalent | Intermedics, Inc. |
| K782096 | INSTRUMENTS, OVERREFRACTION SYSTEM | Jan 26, 1979 | Substantially Equivalent | Zeiss Humphrey System |
| K781440 | LENSOMETER MODEL 11 | Sep 07, 1978 | Substantially Equivalent | Rodenstock Instrument Corp. |
FEI Numbers
This FDA classification entry is associated with 64 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 65 registration numbers. Click on an entry to view related FDA registrations.