The following data is part of a premarket notification filed by Mt.derm Gmbh with the FDA for Exceed Microneedling Device.
| Device ID | K180778 |
| 510k Number | K180778 |
| Device Name: | Exceed Microneedling Device |
| Classification | Powered Microneedle Device |
| Applicant | MT.DERM GmbH Gustav-Krone-Str.3 Berlin, DE 14167 |
| Contact | Anderas 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 | 2018-03-26 |
| Decision Date | 2018-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EMTDEMNPAED06USMP0 | K180778 | 000 |
| EMTDE100201USMP1 | K180778 | 000 |
| EMTDE100201USMP0 | K180778 | 000 |
| EMTDAD61USMP1 | K180778 | 000 |
| EMTDAD61USMP0 | K180778 | 000 |
| EMTDEMNPA4206USMP1 | K180778 | 000 |
| EMTDE104201USMP0 | K180778 | 000 |
| EMTDAD64201USMP0 | K180778 | 000 |