Sectum
Massager, Vacuum, Radio Frequency Induced Heat
Neauvia North America
The following data is part of a premarket notification filed by Neauvia North America with the FDA for Sectum.
Pre-market Notification Details
| Device ID | K202780 |
| 510k Number | K202780 |
| Device Name: | Sectum |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | Neauvia North America 8480 Honeycutt Road Raleigh, NC 27615 |
| Contact | Misty Williams |
| Correspondent | Joy Willard Neauvia North America 8480 Honeycutt Road Raleigh, NC 27615 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-22 |
| Decision Date | 2021-07-30 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850017374171 | K202780 | 000 |
| 00850017374164 | K202780 | 000 |
| 00850017374157 | K202780 | 000 |
| 00850017374140 | K202780 | 000 |
| 00850017374133 | K202780 | 000 |
| 00850017374126 | K202780 | 000 |
Trademark Results [Sectum]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SECTUM 79300575 not registered Live/Pending |
BERGER & KRAFT MEDICAL Sp. z o. o. 2020-09-18 |
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