The following data is part of a premarket notification filed by Eclipsemed Global, Inc with the FDA for Equinox Co2 Laser System.
| Device ID | K100487 |
| 510k Number | K100487 |
| Device Name: | EQUINOX CO2 LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | ECLIPSEMED GLOBAL, INC 16850 DALLAS PARKWAY Dallas, TX 75248 |
| Contact | Connie Hoy |
| Correspondent | Connie Hoy ECLIPSEMED GLOBAL, INC 16850 DALLAS PARKWAY Dallas, TX 75248 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-19 |
| Decision Date | 2010-11-29 |
| Summary: | summary |