NIDEK MODEL YC-1200
FDA 510(k) clearance K893987 · decided 1989-08-18
Clearance details
- K-number
- K893987
- Device name
- NIDEK MODEL YC-1200
- Applicant
- Nidek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-05
- Decision date
- 1989-08-18
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- LXS
- Device class
- 2
- Regulation number
- 886.4392
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- El Toro, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MICRORUPTER V (K023045) | Meridian AG | 2002-09-26 |
| PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. (K901605) | Phoenix Laser Systems, Inc. | 1990-12-13 |
| MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP (K895864) | Lasag AG | 1989-12-29 |
| NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS (K892204) | Nidek, Inc. | 1989-06-22 |
| ISL QC 2000 (K892058) | Intelligent Surgical Lasers, Inc. | 1989-06-15 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment o recall (Z-1367-2015) | Nidek Inc | 2015-04-02 |
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 |