The following data is part of a premarket notification filed by Omniguide Communications, Inc. with the FDA for Omniguide Beampath Co2 Mark I Laser Beam Delivery.
| Device ID | K050541 |
| 510k Number | K050541 |
| Device Name: | OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY |
| Classification | Laser, Ophthalmic |
| Applicant | OMNIGUIDE COMMUNICATIONS, INC. ONE KENDALL SQUARE, BLDG 100 3RD FLOOR Cambridge, MA 02139 |
| Contact | Irina Kulinets |
| Correspondent | Irina Kulinets OMNIGUIDE COMMUNICATIONS, INC. ONE KENDALL SQUARE, BLDG 100 3RD FLOOR Cambridge, MA 02139 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-02 |
| Decision Date | 2005-05-09 |
| Summary: | summary |