The following data is part of a premarket notification filed by Iridex Corp. with the FDA for Iridex Otoprobe Long And Short Angles, P/n 14310-1 And 14320-1.
| Device ID | K060905 |
| 510k Number | K060905 |
| Device Name: | IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View, CA 94043 |
| Contact | John Jossy |
| Correspondent | John Jossy IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View, CA 94043 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-03 |
| Decision Date | 2006-05-31 |
| Summary: | summary |