FDA Product Code
FDA Product Code HLM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1425
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K944022 | LENSCHEK | Leica, Inc. | 1994-11-17 | Traditional | PDF ↗ |
| K940997 | AL-3300 | Hoya Corp. USA | 1994-09-29 | Traditional | PDF ↗ |
| K936199 | AUTOMATIC LENSOMETER | Canon USA, Inc. | 1994-09-28 | Traditional | PDF ↗ |
| K930441 | MARCO STANDARD LENSMETERS 101,201 | Marco Ophthalmic, Inc. | 1993-07-06 | Traditional | PDF ↗ |
| K930445 | MARCO LM-770 DIGITAL PROJECTION LENSMETER | Marco Ophthalmic, Inc. | 1993-06-21 | Traditional | PDF ↗ |
| K924788 | BURTON LENSMETER | R.H. Burton Co. | 1993-04-05 | Traditional | PDF ↗ |
| K924776 | BURTON LENSMETER - MODEL 2021 | R.H. Burton Co. | 1993-04-05 | Traditional | PDF ↗ |
| K924785 | BURTON RADIUSGAUGE - MODEL 2030 | R.H. Burton Co. | 1993-04-05 | Traditional | PDF ↗ |
| K920861 | WOODLYN CLASSIC LENSMETER | Woodlyn, Inc. | 1992-07-30 | Traditional | PDF ↗ |
| K884188 | NIDEK LM-870 AUTOMATIC LENSMETER | Nidek, Inc. | 1988-11-23 | Traditional | PDF ↗ |
| K862518 | BAUSCH & LOMB VERTOMETER V-5 | Bausch & Lomb, Inc. | 1986-08-11 | Traditional | PDF ↗ |
| K861064 | LM-850 AUTOMATIC LENSMETER | Nidek, Inc. | 1986-04-15 | Traditional | PDF ↗ |
| K801767 | DIMENSION I REFRACTION SYSTEM | Smr | 1980-09-16 | Traditional | PDF ↗ |
| K791521 | VERI-VU LENSOMETER | Intermedics, Inc. | 1979-10-30 | Traditional | PDF ↗ |
| K782096 | INSTRUMENTS, OVERREFRACTION SYSTEM | Zeiss Humphrey System | 1979-01-26 | Traditional | PDF ↗ |
| K781440 | LENSOMETER MODEL 11 | Rodenstock Instrument Corp. | 1978-09-07 | Traditional | PDF ↗ |
Product code HLM · Class I · Ophthalmic. Data: openFDA.