HLM
16 FDA 510(k) clearances · Product code
146 daysmedian time to decision
209 days90th percentile
16clearances measured
FDA profile
- Official device name
- Instrument, Measuring, Lens, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1425
- Medical specialty
- Ophthalmic
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| NIDEK LM-870 AUTOMATIC LENSMETER (K884188) | Nidek, Inc. | 1988-11-23 |
| 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 |
| VERI-VU LENSOMETER (K791521) | Intermedics, Inc. | 1979-10-30 |
| INSTRUMENTS, OVERREFRACTION SYSTEM (K782096) | Zeiss Humphrey System | 1979-01-26 |
| LENSOMETER MODEL 11 (K781440) | Rodenstock Instrument Corp. | 1978-09-07 |
Track HLM automatically
Every clearance here is in the API, with alerts when new ones post.