The following data is part of a premarket notification filed by Iridex Corp. with the FDA for Txcell Scanning Laser Delivery System.
| Device ID | K121475 |
| 510k Number | K121475 |
| Device Name: | TXCELL SCANNING LASER DELIVERY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | IRIDEX CORP. 1212 Terra Bella Ave Mountain View, CA 94043 |
| Contact | Paul H Hardiman |
| Correspondent | Paul H Hardiman 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 | 2012-05-18 |
| Decision Date | 2012-11-28 |
| Summary: | summary |