EpilME
Powered Laser Surgical Instrument
Neauvia North America
The following data is part of a premarket notification filed by Neauvia North America with the FDA for Epilme.
Pre-market Notification Details
| Device ID | K213261 |
| 510k Number | K213261 |
| Device Name: | EpilME |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Neauvia North America 8480 Honeycutt Road Raleigh, NC 27615 |
| Contact | Joy Willard |
| Correspondent | Joy Willard Neauvia North America 8480 Honeycutt Road Raleigh, NC 27615 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-06-02 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850017374201 | K213261 | 000 |
Trademark Results [EpilME]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EPILME 97305342 not registered Live/Pending |
Neauvia North America, Inc. 2022-03-10 |
 EPILME 79366187 not registered Live/Pending |
MATEX LAB SWITZERLAND SA 2022-06-09 |
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