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 |