The following data is part of a premarket notification filed by Omniguide, Inc. with the FDA for Omniguide Beampath Fels 25a Co2 Laser System.
| Device ID | K093251 |
| 510k Number | K093251 |
| Device Name: | OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OMNIGUIDE, INC. ONE KENDALL SQUARE, BLDG 100 3RD FLOOR Cambridge, MA 02139 |
| Contact | Douglas W Woodruff |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-16 |
| Decision Date | 2009-10-29 |
| Summary: | summary |