Product code HLM
- Device name
- Instrument, Measuring, Lens, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1425
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944022 | LENSCHEK | Leica, Inc. | 1994-11-17 |
| K940997 | AL-3300 | Hoya Corp. USA | 1994-09-29 |
| K936199 | AUTOMATIC LENSOMETER | Canon USA, Inc. | 1994-09-28 |
| K930441 | MARCO STANDARD LENSMETERS 101,201 | Marco Ophthalmic, Inc. | 1993-07-06 |
| K930445 | MARCO LM-770 DIGITAL PROJECTION LENSMETER | Marco Ophthalmic, Inc. | 1993-06-21 |
| K924776 | BURTON LENSMETER - MODEL 2021 | R.H. Burton Co. | 1993-04-05 |
| K924785 | BURTON RADIUSGAUGE - MODEL 2030 | R.H. Burton Co. | 1993-04-05 |
| K924788 | BURTON LENSMETER | R.H. Burton Co. | 1993-04-05 |
| K920861 | WOODLYN CLASSIC LENSMETER | Woodlyn, Inc. | 1992-07-30 |
| K884188 | NIDEK LM-870 AUTOMATIC LENSMETER | Nidek, Inc. | 1988-11-23 |
| K862518 | BAUSCH & LOMB VERTOMETER V-5 | Bausch & Lomb, Inc. | 1986-08-11 |
| K861064 | LM-850 AUTOMATIC LENSMETER | Nidek, Inc. | 1986-04-15 |
| K801767 | DIMENSION I REFRACTION SYSTEM | Smr | 1980-09-16 |
| K791521 | VERI-VU LENSOMETER | Intermedics, Inc. | 1979-10-30 |
| K782096 | INSTRUMENTS, OVERREFRACTION SYSTEM | Zeiss Humphrey System | 1979-01-26 |
| K781440 | LENSOMETER MODEL 11 | Rodenstock Instrument Corp. | 1978-09-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04540008320138 | Rexxam | REXXAM CO., LTD. | 2026-04-20 |
| 04540008320145 | Rexxam | REXXAM CO., LTD. | 2026-04-20 |
| 04540008320152 | Rexxam | REXXAM CO., LTD. | 2026-04-20 |
| 04987669204924 | AUTO LENSMETER | NIDEK CO.,LTD. | 2026-04-20 |
| 04987669204979 | AUTO LENSMETER | NIDEK CO.,LTD. | 2026-04-20 |
| 04987669205020 | AUTO LENSMETER | NIDEK CO.,LTD. | 2026-04-20 |
| 00860014277535 | S4Optik AL 2000 Digital Lensmeter | Lombart Brothers, Inc. | 2025-10-18 |
| 03664188000602 | VISIONIX | LUNEAU TECHNOLOGY OPERATIONS | 2025-09-05 |
| 00812559012287 | LensChekPro | REICHERT, INC. | 2025-08-12 |
| 00812559012270 | LensChekPlus | REICHERT, INC. | 2025-08-12 |
| 08034028770524 | TOPCON | VISIA IMAGING SRL | 2025-02-20 |
| 06971922131292 | YEASN | Chongqing Yeasn Science & Technology Co.,Ltd. | 2024-08-08 |
| 04562123288384 | COMPUTERIZED LENSMETER CL-300 | TOPCON CORPORATION | 2023-12-19 |
| 04562123288391 | COMPUTERIZED LENSMETER CL-300 | TOPCON CORPORATION | 2023-12-19 |
| 03615020000038 | ALM500 | ESSILOR INTERNATIONAL | 2023-10-03 |
| 03615020000120 | ALM700 | ESSILOR INTERNATIONAL | 2023-10-03 |
| 03615020000236 | ALM800 | ESSILOR INTERNATIONAL | 2023-10-03 |
| 72900189938040 | MyRx LensScaner | 6 OVER 6 VISION LTD | 2023-08-30 |
| 07290018993804 | MyRx LensScaner | 6 OVER 6 VISION LTD | 2023-08-30 |
| 03664188000329 | Visionix | LUNEAU TECHNOLOGY OPERATIONS | 2023-06-08 |
| 03664188000541 | Visionix | LUNEAU TECHNOLOGY OPERATIONS | 2023-06-08 |
| 08800074500244 | Auto Lensmeter | VIEW-M TECHNOLOGY CO., LTD. | 2023-01-10 |
| 08800074500251 | Auto Lensmeter | VIEW-M TECHNOLOGY CO., LTD. | 2023-01-10 |
| 05070000542829 | Atlas | Eyoto, Inc. | 2022-11-17 |
| 05070000542836 | Atlas | Eyoto, Inc. | 2022-11-17 |
| 08034028770401 | TOPCON | VISIA IMAGING SRL | 2022-09-15 |
| 04562123280531 | PRISM COMPENSATOR for LENSMETER LM-8 | TOPCON CORPORATION | 2022-08-31 |
| 06971922131070 | YEASN | Chongqing Yeasn Science & Technology Co.,Ltd. | 2022-04-21 |
| 06971922131674 | YEASN | Chongqing Yeasn Science & Technology Co.,Ltd. | 2022-04-21 |
| 00851158007607 | Eli Ezer | U.S. OPHTHALMIC, L.L.C. | 2020-06-12 |