The following data is part of a premarket notification filed by Meridian Ag with the FDA for Laser Indirect Ophthalmoscope 500(lio-500).
| Device ID | K113390 |
| 510k Number | K113390 |
| Device Name: | LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MERIDIAN AG 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls MERIDIAN AG 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-16 |
| Decision Date | 2012-02-14 |
| Summary: | summary |