OPD-STATION SOFTWARE
FDA 510(k) clearance K050336 · decided 2005-08-24
Clearance details
- K-number
- K050336
- Device name
- OPD-STATION SOFTWARE
- Applicant
- Nidek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-10
- Decision date
- 2005-08-24
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- NCF
- Device class
- 1
- Regulation number
- 886.1760
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Lake Forest, 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 |
|---|---|---|
| LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K062930) | Alcon Research, Ltd. | 2006-11-08 |
| ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K023249) | Alcon Laboratories, Inc. | 2002-10-18 |
| CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) (K000637) | Alcon Laboratories, Inc. | 2000-05-19 |
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 |