NIDEK LM-870 AUTOMATIC LENSMETER
FDA 510(k) clearance K884188 · decided 1988-11-23
Clearance details
- K-number
- K884188
- Device name
- NIDEK LM-870 AUTOMATIC LENSMETER
- Applicant
- Nidek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-10-05
- Decision date
- 1988-11-23
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- HLM
- Device class
- 1
- Regulation number
- 886.1425
- 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 |
|---|---|---|
| LENSCHEK (K944022) | Leica, Inc. | 1994-11-17 |
| AL-3300 (K940997) | Hoya Corp. USA | 1994-09-29 |
| AUTOMATIC LENSOMETER (K936199) | Canon USA, Inc. | 1994-09-28 |
| MARCO STANDARD LENSMETERS 101,201 (K930441) | Marco Ophthalmic, Inc. | 1993-07-06 |
| MARCO LM-770 DIGITAL PROJECTION LENSMETER (K930445) | Marco Ophthalmic, Inc. | 1993-06-21 |
| BURTON LENSMETER - MODEL 2021 (K924776) | R.H. Burton Co. | 1993-04-05 |
| BURTON RADIUSGAUGE - MODEL 2030 (K924785) | R.H. Burton Co. | 1993-04-05 |
| BURTON LENSMETER (K924788) | R.H. Burton Co. | 1993-04-05 |
| WOODLYN CLASSIC LENSMETER (K920861) | Woodlyn, Inc. | 1992-07-30 |
| BAUSCH & LOMB VERTOMETER V-5 (K862518) | Bausch & Lomb, Inc. | 1986-08-11 |
| LM-850 AUTOMATIC LENSMETER (K861064) | Nidek, Inc. | 1986-04-15 |
| DIMENSION I REFRACTION SYSTEM (K801767) | Smr | 1980-09-16 |
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 |