Product code HLQ
- Device name
- Keratoscope, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1350
- 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 |
|---|---|---|---|
| K003299 | OPD-SCAN, MODELS ARK-10000 AND ARK-9000 | Nidek Co., Ltd. | 2001-03-09 |
| K973756 | EYE SYS VISTA | Eyesys Technologies, Inc. | 1997-11-13 |
| K964290 | EYECHEK | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 1997-01-09 |
| K945382 | TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER | Expertech Assoc., Inc. | 1995-01-31 |
| K944207 | TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 | Computed Anatomy, Inc. | 1994-12-07 |
| K944616 | KERATRON CORNEAL TOPOGRAPHER | Alliance Medical Marketinig | 1994-11-22 |
| K940647 | ORBSCAN(TM) KERATOMETER | Orbtek, Inc. | 1994-07-06 |
| K933556 | EH-270 CORNEAL TOPOGRAPHER | Visioptic, Inc. | 1993-11-02 |
| K923435 | CORNEAL TOPOGRAPHY SYSTEM | Par Microsystems Corp. | 1993-02-16 |
| K922253 | KERATOREF L60 | Luneau Ophtalmologie SA | 1992-06-19 |
| K912740 | ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) | Visionary Systems, Inc. | 1991-12-30 |
| K913022 | CCI VIDEOKERATOSCOPE/COMPARATOR | Cci | 1991-10-09 |
| K912130 | TBD KERATOSCOPE | Alcon Laboratories | 1991-08-09 |
| K895741 | CLAS PHOTOKERATOSCOPE | Kera-Metrics Corp. | 1990-07-11 |
| K902012 | VKS-1 VIDEO KERATOSCOPE | Computed Anatomy, Inc. | 1990-06-22 |
| K901009 | MODEL 2000 INTRAOPERATIVE CORNEASCOPE | Kera Corp. | 1990-05-30 |
| K901363 | TOPOGRAPHIC MODELING SYSTEM | Computed Anatomy, Inc. | 1990-05-25 |
| K895475 | CANON AUTO REF-KERATOMETER RK-2 | Canon USA, Inc. | 1989-10-31 |
| K890687 | ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER | Optimed, Inc. | 1989-09-05 |
| K871936 | CANON SURGICAL AUTO KERATOMETER SK-1 | Canon USA, Inc. | 1987-06-19 |
| K871479 | VIDEOSCAN (TM) | Kera Corp. | 1987-05-22 |
| K862137 | NIDEK KM-1000 SURGICAL KERATOMETER | Nidek, Inc. | 1986-07-23 |
| K861063 | NIDEK KM-800 AUTO KERATOMETER | Nidek, Inc. | 1986-04-04 |
| K853723 | ZEISS OPERATING KERATOMETER | Carl Zeiss, Inc. | 1985-10-15 |
| K853668 | ORC ORACLE | Optical Radiation Corp. | 1985-10-15 |
| K850665 | CORNEASCOPE MODEL 1200 | Kera Corp. | 1985-03-20 |
| K841765 | WOODLYN STANDARD SLIT LAMP HSSL-ST | Woodlyn, Inc. | 1984-08-07 |
| K831084 | SUN PHOTO-KERATOSCOPE | Nidek, Inc. | 1983-06-30 |
| K781994 | AUTOKERATOMETER, INSTRUMENT | Zeiss Humphrey System | 1979-02-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09349221000033 | Medmont Corneal Topographer E300 USB | MEDMONT INTERNATIONAL PTY LTD | 2022-09-14 |
| 07630003570908 | Leica Keratoscope | Leica Microsystems (Schweiz) AG | 2020-09-25 |
| 04987669101476 | AUTO REF/KERATOMETER | NIDEK CO.,LTD. | 2019-02-22 |
| 06945033902010 | TIANNUO / TNMED | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 2018-09-24 |
| 06945033902027 | TIANNUO / TNMED | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 2018-09-24 |
| 04987669100714 | AUTO REF/KERATOMETER | NIDEK CO.,LTD. | 2018-04-20 |
| 04987669100721 | AUTO REF/KERATOMETER | NIDEK CO.,LTD. | 2018-04-20 |
| 04987669100745 | AUTO REF/KERATOMETER | NIDEK CO.,LTD. | 2018-04-20 |
| 04987669100769 | HANDHELD REF / KERATOMETER | NIDEK CO.,LTD. | 2018-04-20 |
| 00869228000472 | IBEX Keratometer | Trevi Technology, Inc. | 2018-01-01 |
| 04049584000217 | Park 1 | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2016-09-01 |
| 04987669100776 | REFRACTIVE POWER / CORNEAL ANALYZER | NIDEK CO.,LTD. | 2016-08-19 |
| 04987669100738 | AUTO REF/KERATOMETER | NIDEK CO.,LTD. | 2016-08-10 |
| 04987669100066 | AUTO REF/KERATO/TONOMETER | NIDEK CO.,LTD. | 2016-06-24 |