The following data is part of a premarket notification filed by Eclipse Aesthetics, Llc with the FDA for Equinox Co2 Laser.
| Device ID | K131903 |
| 510k Number | K131903 |
| Device Name: | EQUINOX CO2 LASER |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | ECLIPSE AESTHETICS, LLC 13988 Diplomat Dr Suite 160 Dallas, TX 75234 |
| Contact | Tom O'brien |
| Correspondent | Tom O'brien ECLIPSE AESTHETICS, LLC 13988 Diplomat Dr Suite 160 Dallas, TX 75234 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2013-09-19 |
| Summary: | summary |