Instrument, Measuring, Lens, Ac-Powered

FDA product code HLM · Class I (low risk) · 21 CFR 886.1425 · Ophthalmic

16510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K944022LenschekHLM · Traditional Leica, Inc.11/17/1994SE
K940997AL-3300HLM · Traditional Hoya Corp. USA09/29/1994SE
K936199Automatic LensometerHLM · Traditional Canon USA, Inc.09/28/1994SE
K930441Marco Standard Lensmeters 101,201HLM · Traditional Marco Ophthalmic, Inc.07/06/1993SE
K930445Marco LM-770 Digital Projection LensmeterHLM · Traditional Marco Ophthalmic, Inc.06/21/1993SE
K924788Burton LensmeterHLM · Traditional R.H. Burton Co.04/05/1993SE
K924785Burton Radiusgauge - Model 2030HLM · Traditional R.H. Burton Co.04/05/1993SE
K924776Burton Lensmeter - Model 2021HLM · Traditional R.H. Burton Co.04/05/1993SE
K920861Woodlyn Classic LensmeterHLM · Traditional Woodlyn, Inc.07/30/1992SE
K884188Nidek LM-870 Automatic LensmeterHLM · Traditional Nidek, Inc.11/23/1988SE
K862518Bausch & Lomb Vertometer V-5HLM · Traditional Bausch & Lomb, Inc.08/11/1986SE
K861064LM-850 Automatic LensmeterHLM · Traditional Nidek, Inc.04/15/1986SE
K801767Dimension I Refraction SystemHLM · Traditional Smr09/16/1980SE
K791521Veri-Vu LensometerHLM · Traditional Intermedics, Inc.10/30/1979SE
K782096Instruments, Overrefraction SystemHLM · Traditional Zeiss Humphrey System01/26/1979SE
K781440Lensometer Model 11HLM · Traditional Rodenstock Instrument Corp.09/07/1978SE

Recalls

RecallProductFirmInitiated
Z-0613-2021 Class IICarl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for…Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the… Carl Zeiss Meditec AG08/06/2020Terminated