The Exceed microneedling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. Exceed…
The Exceed microneedling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. Exceed consists of – Control Unit – Handpiece with handpiece cable – Handpiece Holder – Power Supply – Instructions for Use
Who Else Makes It
Concentrated in Beijing (4), Guangdong (4), Hebei (2). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Bio Touch Precision | Listed by | Mt.derm GmbH, Germany |
| FDA product code | QAI |
| Device type | Powered Microneedle Device |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4430 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K180778 |
| Record published | 2026-05-22 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 14 to 104 °F; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 54 to 107 KiloPascal; Handling environment temperature 59 to 77 °F; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 70 to 107 KiloPascal |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.