The following data is part of a premarket notification filed by Omniguide, Inc with the FDA for Beacon Advanced Co2 Laser System.
| Device ID | K180993 |
| 510k Number | K180993 |
| Device Name: | Beacon Advanced CO2 Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OmniGuide, Inc 4 Maguire Road Lexington, MA 02421 |
| Contact | Sam Wade |
| Correspondent | Sam Wade OmniGuide, Inc 4 Maguire Road Lexington, MA 02421 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-16 |
| Decision Date | 2018-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852306007715 | K180993 | 000 |