The following data is part of a premarket notification filed by Mt. Derm Gmbh with the FDA for Exceed Microneedling Device.
| Device ID | K182407 |
| 510k Number | K182407 |
| Device Name: | Exceed Microneedling Device |
| Classification | Powered Microneedle Device |
| Applicant | Mt. Derm GmbH Gustav-Krone-Str.3 Berlin, DE 14167 |
| Contact | Andreas Pachten |
| Correspondent | Susan D'arcy Ismart Marketing Svcs 129 Green Lanes, Wylde Green Birmingham, GB B735lt |
| Product Code | QAI |
| CFR Regulation Number | 878.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-04 |
| Decision Date | 2019-07-19 |