The following data is part of a premarket notification filed by Omniguide, Inc. with the FDA for Trio Handpiece.
| Device ID | K183199 |
| 510k Number | K183199 |
| Device Name: | TRIO Handpiece |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OmniGuide, Inc. 4 Maguire Road Lexington, MA 02412 |
| Contact | Samuel Wade |
| Correspondent | Samuel Wade OmniGuide, Inc. 4 Maguire Road Lexington, MA 02412 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852306007708 | K183199 | 000 |