The Bio touch Aero is a variant of Exceed Unlimited. The Exceed Unlimited device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin…
The Bio touch Aero is a variant of Exceed Unlimited. The Exceed Unlimited device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. The Exceed Unlimited device consists of 7 component parts; Handpiece, sterile single use Safety needle cartridge, Handpiece holder, Barrier Sleeve, Battery, Charger incl. USB cable, power supply. The handpiece contains a motor that moves the needles. The handpiece receives power via a Li-Ion battery with an output of 3,7 V. The battery charger receives power from a standard 100-240V, 50- 60Hz, 0.45A wall socket transformer with an USB output of 5 V, 3.2A.
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 Aero | 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) | K233709 |
| 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 -4 to 113 °F; Storage environment humidity 20 to 80 % 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 54 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.