| Device Type ID | 4295 |
| Device Name | Laser, Ophthalmic |
| Regulation Description | Ophthalmic Laser. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Contact Lenses And Retinal Devices Branch (CLRD) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.4390 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HQF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 4295 |
| Device | Laser, Ophthalmic |
| Product Code | HQF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ophthalmic Laser. |
| CFR Regulation Number | 886.4390 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CARL ZEISS MEDITEC INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARL ZEISS MEDITEC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELLEX MEDICAL PTY. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELLEX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KATALYST SURGICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIGHTMED CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIGHTMED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUTRONIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIDEK CO | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
NIDEK CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OPHTHALMED LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUANTEL MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TOPCON MEDICAL LASER SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Laser | 55 |
Device Operates Differently Than Expected | 30 |
Adverse Event Without Identified Device Or Use Problem | 29 |
Device Operational Issue | 19 |
System | 16 |
Unexpected Therapeutic Results | 15 |
Failure To Deliver Energy | 12 |
Probe | 9 |
Insufficient Information | 9 |
Misfocusing | 8 |
Output Problem | 8 |
Energy Output Problem | 7 |
Failure To Fire | 7 |
Power Problem | 6 |
Output Below Specifications | 6 |
Loss Of Power | 6 |
Device Displays Incorrect Message | 5 |
Self-Activation Or Keying | 4 |
Appropriate Term/Code Not Available | 4 |
Device Inoperable | 4 |
Defective Component | 3 |
Operating System Becomes Nonfunctional | 3 |
Switches | 3 |
Component Or Accessory Incompatibility | 3 |
Protective Measures Problem | 2 |
Material Separation | 2 |
Calibration Problem | 2 |
Nonstandard Device | 2 |
Overheating Of Device | 2 |
Inadequate User Interface | 2 |
Energy Output To Patient Tissue Incorrect | 2 |
Difficult To Remove | 1 |
Sparking | 1 |
Improper Device Output | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 |
Continuous Firing | 1 |
Output Above Specifications | 1 |
No Display / Image | 1 |
Inadequate Instructions For Healthcare Professional | 1 |
Smoking | 1 |
Use Of Device Problem | 1 |
Suction Problem | 1 |
Physical Property Issue | 1 |
No Apparent Adverse Event | 1 |
Failure To Align | 1 |
Defective Device | 1 |
Failure To Shut Off | 1 |
Temperature Problem | 1 |
Knife | 1 |
Computer Software Problem | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Inadequate Or Insufficient Training | 1 |
Application Program Problem | 1 |
Use Of Incorrect Control Settings | 1 |
Environmental Particulates | 1 |
Installation-Related Problem | 1 |
Device Handling Problem | 1 |
Monitor | 1 |
Fitting Problem | 1 |
| Total Device Problems | 314 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bausch & Lomb Inc | II | Dec-23-2014 |
| 2 | Carl Zeiss Meditec AG | II | Mar-07-2014 |
| 3 | Laserex Systems Inc. | II | Apr-07-2016 |
| 4 | Lumenis, Inc. | II | Sep-30-2014 |
| 5 | Nidek Inc | II | Feb-19-2015 |
| 6 | Nidek Inc | II | Nov-17-2014 |
| 7 | Nidek Inc | II | Nov-17-2014 |
| 8 | Nidek Inc | II | Jul-30-2014 |
| 9 | Topcon Medical Laser Systems, Inc | II | Aug-11-2016 |
| 10 | Ziemer Usa Inc | II | Jan-15-2015 |
| 11 | Ziemer Usa Inc | II | Jan-23-2014 |