| Device Type ID | 4235 |
| Device Name | Keratome, Ac-powered |
| Regulation Description | Keratome. |
| 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 | 886.4370 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HNO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 4235 |
| Device | Keratome, Ac-powered |
| Product Code | HNO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Keratome. |
| CFR Regulation Number | 886.4370 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CARL ZEISS MEDITEC INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARL ZEISS MEDITEC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Suction Problem | 4136 |
Adverse Event Without Identified Device Or Use Problem | 2119 |
Device Operates Differently Than Expected | 123 |
Device Displays Incorrect Message | 39 |
Scratched Material | 30 |
Failure To Cut | 22 |
Unexpected Therapeutic Results | 13 |
Laser | 11 |
Handpiece | 10 |
Failure To Advance | 9 |
Mechanical Problem | 9 |
Device Contamination With Chemical Or Other Material | 7 |
Noise, Audible | 4 |
Appropriate Term/Code Not Available | 4 |
Smoking | 4 |
Retraction Problem | 2 |
Electrical /Electronic Property Problem | 2 |
Break | 2 |
Temperature Problem | 2 |
Accessory Incompatible | 2 |
Therapy Delivered To Incorrect Body Area | 2 |
Failure To Power Up | 2 |
Out-Of-Box Failure | 1 |
Use Of Incorrect Control Settings | 1 |
Positioning Failure | 1 |
Reflux Within Device | 1 |
Sticking | 1 |
Dent In Material | 1 |
Electrical Shorting | 1 |
Poor Quality Image | 1 |
Optical Problem | 1 |
Unintended Movement | 1 |
Insufficient Information | 1 |
Device Expiration Issue | 1 |
Failure To Align | 1 |
Calibration Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Thermal Decomposition Of Device | 1 |
Computer Software Problem | 1 |
Decrease In Suction | 1 |
Erratic Or Intermittent Display | 1 |
Malposition Of Device | 1 |
Positioning Problem | 1 |
Contamination / Decontamination Problem | 1 |
Gradient Increase | 1 |
Power Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Defective Component | 1 |
Contamination During Use | 1 |
Energy Output Problem | 1 |
Human-Device Interface Problem | 1 |
Energy Output To Patient Tissue Incorrect | 1 |
Expiration Date Error | 1 |
| Total Device Problems | 6585 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Med-logics Inc | II | Mar-13-2015 |