| Device Type ID | 4339 |
| Device Name | Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Regulation Description | Nd:YAG Laser For Posterior Capsulotomy And Peripheral Iridotomy. |
| 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 | 886.4392 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LXS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 4339 |
| Device | Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Product Code | LXS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nd:YAG Laser For Posterior Capsulotomy And Peripheral Iridotomy. |
| CFR Regulation Number | 886.4392 [🔎] |
| Device Problems | |
|---|---|
Laser | 30 |
Unexpected Therapeutic Results | 15 |
Device Operates Differently Than Expected | 8 |
Misfocusing | 5 |
Nonstandard Device | 5 |
Energy Output Problem | 3 |
Material Integrity Problem | 2 |
Energy Output To Patient Tissue Incorrect | 2 |
Output Problem | 2 |
Mechanics Altered | 2 |
Optical Problem | 2 |
System | 1 |
Firing Problem | 1 |
Grounding Malfunction | 1 |
Failure To Fire | 1 |
Electrical /Electronic Property Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
IOL (Intraocular Lens) Implant | 1 |
Intermittent Shock | 1 |
| Total Device Problems | 84 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Nidek Inc | II | Apr-02-2015 |