NIDEK KM-1000 SURGICAL KERATOMETER
FDA 510(k) clearance K862137 · decided 1986-07-23
Clearance details
- K-number
- K862137
- Device name
- NIDEK KM-1000 SURGICAL KERATOMETER
- Applicant
- Nidek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-06-04
- Decision date
- 1986-07-23
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- HLQ
- Device class
- 1
- Regulation number
- 886.1350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OPD-SCAN, MODELS ARK-10000 AND ARK-9000 (K003299) | Nidek Co., Ltd. | 2001-03-09 |
| EYE SYS VISTA (K973756) | Eyesys Technologies, Inc. | 1997-11-13 |
| EYECHEK (K964290) | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 1997-01-09 |
| TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER (K945382) | Expertech Assoc., Inc. | 1995-01-31 |
| TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 (K944207) | Computed Anatomy, Inc. | 1994-12-07 |
| KERATRON CORNEAL TOPOGRAPHER (K944616) | Alliance Medical Marketinig | 1994-11-22 |
| ORBSCAN(TM) KERATOMETER (K940647) | Orbtek, Inc. | 1994-07-06 |
| EH-270 CORNEAL TOPOGRAPHER (K933556) | Visioptic, Inc. | 1993-11-02 |
| CORNEAL TOPOGRAPHY SYSTEM (K923435) | Par Microsystems Corp. | 1993-02-16 |
| KERATOREF L60 (K922253) | Luneau Ophtalmologie SA | 1992-06-19 |
| ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) (K912740) | Visionary Systems, Inc. | 1991-12-30 |
| CCI VIDEOKERATOSCOPE/COMPARATOR (K913022) | Cci | 1991-10-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S016) | Nidek, Inc. | 1990-03-13 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S015) | Nidek, Inc. | 1989-09-08 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S014) | Nidek, Inc. | 1989-08-30 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S012) | Nidek, Inc. | 1988-07-28 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S011) | Nidek, Inc. | 1987-06-11 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S009) | Nidek, Inc. | 1987-04-08 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S010) | Nidek, Inc. | 1986-12-01 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S007) | Nidek, Inc. | 1985-11-26 |