Etherea MX
Powered Laser Surgical Instrument
Vydence Medical Industria E Comercio Ltda
The following data is part of a premarket notification filed by Vydence Medical Industria E Comercio Ltda with the FDA for Etherea Mx.
Pre-market Notification Details
| Device ID | K171443 |
| 510k Number | K171443 |
| Device Name: | Etherea MX |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Vydence Medical Industria E Comercio Ltda Rua Aldo Germano Klein, 359 Cep: 13.573-470 - Caixa Postal 772 Ceat - Sao Carlos/sp Sao Paulo, BR 13.573-470 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor Kathy Maynor 26 Rebecca Ct Homosassa, FL 34446 |
| Product Code | GEX |
| Subsequent Product Code | ILY |
| Subsequent Product Code | ONF |
| Subsequent Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-16 |
| Decision Date | 2018-04-20 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07898961835075 | K171443 | 000 |
| 07898961835099 | K171443 | 000 |
| 07898961835068 | K171443 | 000 |
| 07898961835051 | K171443 | 000 |
| 07898961835044 | K171443 | 000 |
| 07898961835037 | K171443 | 000 |
| 07898961835020 | K171443 | 000 |
| 07898961835013 | K171443 | 000 |
Trademark Results [Etherea MX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ETHEREA MX 87478733 5822313 Live/Registered |
VYDENCE MEDICAL - Industria e Comercio Ltda. 2017-06-07 |
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