INSTRUMENTS, OVERREFRACTION SYSTEM
FDA 510(k) clearance K782096 · decided 1979-01-26
Clearance details
- K-number
- K782096
- Device name
- INSTRUMENTS, OVERREFRACTION SYSTEM
- Applicant
- Zeiss Humphrey System
- Decision
- Substantially Equivalent
- Date received
- 1978-12-18
- Decision date
- 1979-01-26
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- HLM
- Device class
- 1
- Regulation number
- 886.1425
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, MI, 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.