Bare: 808
Powered Laser Surgical Instrument
LUVO Medical Technologies, Inc
The following data is part of a premarket notification filed by Luvo Medical Technologies, Inc with the FDA for Bare: 808.
Pre-market Notification Details
| Device ID | K193446 |
| 510k Number | K193446 |
| Device Name: | Bare: 808 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUVO Medical Technologies, Inc 125 Fleming Dr Cambridge, CA N1t 2b8 |
| Contact | Gregory Berzak |
| Correspondent | Gregory Berzak LUVO Medical Technologies, Inc 125 Fleming Dr Cambridge, CA N1t 2b8 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-12 |
| Decision Date | 2020-03-10 |
Trademark Results [Bare: 808]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BARE: 808 88731950 not registered Live/Pending |
Luvo Medical Technologies Inc. 2019-12-18 |
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