HLQ — Keratoscope, Ac-Powered Class I
FDA product code HLQ covers "Keratoscope, Ac-Powered", a Class I medical device regulated under 21 CFR 886.1350. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HLQ
- Device Class
- Class I
- Regulation Number
- 886.1350
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K003299 | nidek co | OPD-SCAN, MODELS ARK-10000 AND ARK-9000 | March 9, 2001 |
| K973756 | eyesys technologies | EYE SYS VISTA | November 13, 1997 |
| K964290 | reichert ophthalmic instruments, div. leica | EYECHEK | January 9, 1997 |
| K945382 | expertech assoc | TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER | January 31, 1995 |
| K944207 | computed anatomy | TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 | December 7, 1994 |
| K944616 | alliance medical marketinig | KERATRON CORNEAL TOPOGRAPHER | November 22, 1994 |
| K940647 | orbtek | ORBSCAN(TM) KERATOMETER | July 6, 1994 |
| K933556 | visioptic | EH-270 CORNEAL TOPOGRAPHER | November 2, 1993 |
| K923435 | par microsystems | CORNEAL TOPOGRAPHY SYSTEM | February 16, 1993 |
| K922253 | luneau ophtalmologie | KERATOREF L60 | June 19, 1992 |
| K912740 | visionary systems | ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) | December 30, 1991 |
| K913022 | cci | CCI VIDEOKERATOSCOPE/COMPARATOR | October 9, 1991 |
| K912130 | alcon laboratories | TBD KERATOSCOPE | August 9, 1991 |
| K895741 | kera-metrics | CLAS PHOTOKERATOSCOPE | July 11, 1990 |
| K902012 | computed anatomy | VKS-1 VIDEO KERATOSCOPE | June 22, 1990 |
| K901009 | kera | MODEL 2000 INTRAOPERATIVE CORNEASCOPE | May 30, 1990 |
| K901363 | computed anatomy | TOPOGRAPHIC MODELING SYSTEM | May 25, 1990 |
| K895475 | canon usa | CANON AUTO REF-KERATOMETER RK-2 | October 31, 1989 |
| K890687 | optimed | ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER | September 5, 1989 |
| K871936 | canon usa | CANON SURGICAL AUTO KERATOMETER SK-1 | June 19, 1987 |