510(k) K791521
- Device
- Veri-vu Lensometer
- Applicant
- INTERMEDICS, INC.
- 510(k) number
- K791521
- Product code
- HLM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-10-30
- Date received
- 1979-08-10
- Regulation
- 886.1425
- Classification name
- Instrument, Measuring, Lens, Ac-Powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004441848
- 3007123908
- 8040382
- 3011774865
- 3009515444
- 3007913988
- 9616199
- 1000533313
- 9614661
- 3010774780
- 3038356864
- 3003851947
- 8030392
- 3004095901
- 3009173773
- 3005771344
- 3013534308
- 3038287496
- 2952604
- 9615010
- 1836161
- 3006948765
- 3027396409
- 3009275598
- 3011898560
- 3003771740
- 3007817024
- 2085143
- 3014329429
- 3003951061
- 1937310
- 9615030
- 1054713
- 9612297
- 2936921
- 3013316298
- 3014326859
- 3005785090
- 3030057595
- 3008058416
- 3007343325
- 3002807715
- 3013576617
- 1319721
- 3009132348
- 3013148497
- 3013403214
- 3008044477
- 3004167900
- 3003984265
- 5470
- 8020986
- 3008729548
- 3010675798
- 3010610157
- 3008044461
- 3010227033
- 3013436538
- 9617474
- 9610612
- 3004784203
- 3003553186
- 8040381
- 2031962
- 3011110913
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HLM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944022 | LENSCHEK | Leica, Inc. | 1994-11-17 |
| K940997 | AL-3300 | Hoya Corp. USA | 1994-09-29 |
| K936199 | AUTOMATIC LENSOMETER | Canon USA, Inc. | 1994-09-28 |
| K930441 | MARCO STANDARD LENSMETERS 101,201 | Marco Ophthalmic, Inc. | 1993-07-06 |
| K930445 | MARCO LM-770 DIGITAL PROJECTION LENSMETER | Marco Ophthalmic, Inc. | 1993-06-21 |
| K924776 | BURTON LENSMETER - MODEL 2021 | R.H. Burton Co. | 1993-04-05 |
| K924785 | BURTON RADIUSGAUGE - MODEL 2030 | R.H. Burton Co. | 1993-04-05 |
| K924788 | BURTON LENSMETER | R.H. Burton Co. | 1993-04-05 |
| K920861 | WOODLYN CLASSIC LENSMETER | Woodlyn, Inc. | 1992-07-30 |
| K884188 | NIDEK LM-870 AUTOMATIC LENSMETER | Nidek, Inc. | 1988-11-23 |
| K862518 | BAUSCH & LOMB VERTOMETER V-5 | Bausch & Lomb, Inc. | 1986-08-11 |
| K861064 | LM-850 AUTOMATIC LENSMETER | Nidek, Inc. | 1986-04-15 |
| K801767 | DIMENSION I REFRACTION SYSTEM | Smr | 1980-09-16 |
| K782096 | INSTRUMENTS, OVERREFRACTION SYSTEM | Zeiss Humphrey System | 1979-01-26 |
| K781440 | LENSOMETER MODEL 11 | Rodenstock Instrument Corp. | 1978-09-07 |