| Device Type ID | 4154 |
| Device Name | Biomicroscope, Slit-lamp, Ac-powered |
| Regulation Description | AC-powered Slitlamp Biomicroscope. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.1850 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HJO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 4154 |
| Device | Biomicroscope, Slit-lamp, Ac-powered |
| Product Code | HJO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | AC-powered Slitlamp Biomicroscope. |
| CFR Regulation Number | 886.1850 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CARL ZEISS MEDITEC INC | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
CARL ZEISS MEDITEC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
CHONGQING KANGHUA RUIMING S&T CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INNOVATIVE VISUAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KEELER LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KOWA CO. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIDEK CO | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NIDEK CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
REICHERT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUZHOU 66 VISION TECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUZHOU KANGJIE MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TAKAGI SEIKO CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOPCON CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOPCON CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOPCON MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VISIA IMAGING S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 26 |
Incorrect Measurement | 8 |
Output Problem | 5 |
Use Of Incorrect Control Settings | 4 |
Tidal Volume Fluctuations | 4 |
Use Of Device Problem | 3 |
Appropriate Term/Code Not Available | 2 |
Programming Issue | 2 |
Insufficient Information | 2 |
Calibration Problem | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Patient Data Problem | 1 |
Device Handling Problem | 1 |
Device Operates Differently Than Expected | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 65 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Carl Zeiss Meditec AG | II | Oct-15-2018 |
| 2 | Carl Zeiss Meditec AG | II | Dec-01-2015 |
| 3 | Nidek Inc | II | Aug-18-2016 |