510(k) K901009
- Device
- MODEL 2000 INTRAOPERATIVE CORNEASCOPE
- Applicant
- KERA CORP.
- 510(k) number
- K901009
- Product code
- HLQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-05-30
- Date received
- 1990-03-05
- Regulation
- 886.1350
- Classification name
- Keratoscope, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES L ROSE
- Address
- 1963 Rock St. Suite #17 Mountain View CA US 94043 94043
FDA Registration Numbers#
- 3004441848
- 3005785090
- 2031962
- 8020986
- 3007913988
- 3010675798
- 3020246591
- 3002807715
- 3013576617
- 3010227033
- 3010300699
- 3004095901
- 3015972897
- 1054713
- 8030392
- 3005771344
- 3015392301
- 2936921
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HLQ #
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases