The following data is part of a premarket notification filed by Sandstone Medical Technologies, Llc with the FDA for Cortex Co2 / Er:yag Laser System.
| Device ID | K110897 |
| 510k Number | K110897 |
| Device Name: | CORTEX CO2 / ER:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SANDSTONE MEDICAL TECHNOLOGIES, LLC 105 CITATION COURT Homewood, AL 35209 |
| Contact | Mark Rohrer |
| Correspondent | Mark Rohrer SANDSTONE MEDICAL TECHNOLOGIES, LLC 105 CITATION COURT Homewood, AL 35209 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-30 |
| Decision Date | 2011-07-01 |
| Summary: | summary |