FDA Product Code
FDA Product Code HLQ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1350
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K003299 | OPD-SCAN, MODELS ARK-10000 AND ARK-9000 | Nidek Co., Ltd. | 2001-03-09 | Traditional | PDF ↗ |
| K973756 | EYE SYS VISTA | Eyesys Technologies, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K964290 | EYECHEK | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 1997-01-09 | Traditional | PDF ↗ |
| K945382 | TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER | Expertech Assoc., Inc. | 1995-01-31 | Traditional | PDF ↗ |
| K944207 | TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 | Computed Anatomy, Inc. | 1994-12-07 | Traditional | PDF ↗ |
| K944616 | KERATRON CORNEAL TOPOGRAPHER | Alliance Medical Marketinig | 1994-11-22 | Traditional | PDF ↗ |
| K940647 | ORBSCAN(TM) KERATOMETER | Orbtek, Inc. | 1994-07-06 | Traditional | PDF ↗ |
| K933556 | EH-270 CORNEAL TOPOGRAPHER | Visioptic, Inc. | 1993-11-02 | Traditional | PDF ↗ |
| K923435 | CORNEAL TOPOGRAPHY SYSTEM | Par Microsystems Corp. | 1993-02-16 | Traditional | PDF ↗ |
| K922253 | KERATOREF L60 | Luneau Ophtalmologie SA | 1992-06-19 | Traditional | PDF ↗ |
| K912740 | ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) | Visionary Systems, Inc. | 1991-12-30 | Traditional | PDF ↗ |
| K913022 | CCI VIDEOKERATOSCOPE/COMPARATOR | Cci | 1991-10-09 | Traditional | PDF ↗ |
| K912130 | TBD KERATOSCOPE | Alcon Laboratories | 1991-08-09 | Traditional | PDF ↗ |
| K895741 | CLAS PHOTOKERATOSCOPE | Kera-Metrics Corp. | 1990-07-11 | Traditional | PDF ↗ |
| K902012 | VKS-1 VIDEO KERATOSCOPE | Computed Anatomy, Inc. | 1990-06-22 | Traditional | PDF ↗ |
| K901009 | MODEL 2000 INTRAOPERATIVE CORNEASCOPE | Kera Corp. | 1990-05-30 | Traditional | PDF ↗ |
| K901363 | TOPOGRAPHIC MODELING SYSTEM | Computed Anatomy, Inc. | 1990-05-25 | Traditional | PDF ↗ |
| K895475 | CANON AUTO REF-KERATOMETER RK-2 | Canon USA, Inc. | 1989-10-31 | Traditional | PDF ↗ |
| K890687 | ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER | Optimed, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K871936 | CANON SURGICAL AUTO KERATOMETER SK-1 | Canon USA, Inc. | 1987-06-19 | Traditional | PDF ↗ |
| K871479 | VIDEOSCAN (TM) | Kera Corp. | 1987-05-22 | Traditional | PDF ↗ |
| K862137 | NIDEK KM-1000 SURGICAL KERATOMETER | Nidek, Inc. | 1986-07-23 | Traditional | PDF ↗ |
| K861063 | NIDEK KM-800 AUTO KERATOMETER | Nidek, Inc. | 1986-04-04 | Traditional | PDF ↗ |
| K853723 | ZEISS OPERATING KERATOMETER | Carl Zeiss, Inc. | 1985-10-15 | Traditional | PDF ↗ |
| K853668 | ORC ORACLE | Optical Radiation Corp. | 1985-10-15 | Traditional | PDF ↗ |
| K850665 | CORNEASCOPE MODEL 1200 | Kera Corp. | 1985-03-20 | Traditional | PDF ↗ |
| K841765 | WOODLYN STANDARD SLIT LAMP HSSL-ST | Woodlyn, Inc. | 1984-08-07 | Traditional | PDF ↗ |
| K831084 | SUN PHOTO-KERATOSCOPE | Nidek, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K781994 | AUTOKERATOMETER, INSTRUMENT | Zeiss Humphrey System | 1979-02-12 | Traditional | PDF ↗ |
Product code HLQ · Class I · Ophthalmic. Data: openFDA.