Footswitch
Box of Footswitch. The Footswitch is an accessory of Exceed AD61USMP.
10manufacturers in China registered for this device type
5catalogue numbers in this listing
3510(k) clearances naming this product code
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.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Beijing Perfectlaser Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 12 |
| Hebei Lufen Tech Co., Limited | Xingtai | Hebei | Contract manufacturer | 12 |
| Sanhe Jumei Technology Co., Ltd. | Sanhe | Hebei | Manufacturer | 12 |
| Guangzhou Ekai Electronic Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Guangdong Carain Beauty Equipment Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 1 |
Record
| 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 | 2024-01-10 |
| Record revised | 2024-01-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 60 to 107 KiloPascal; Storage environment atmospheric pressure 54 to 107 KiloPascal; Storage environment temperature 14 to 104 °F; Handling environment humidity 30 to 75 % RH; Storage environment humidity 10 to 90 % RH; Handling environment temperature 59 to 77 °F |
| Distribution end date | 2022-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E104802USMP | In distribution | |
| E104902USMP | In distribution | |
| E104201USMP | In distribution | |
| E100201USMP | Withdrawn | |
| E100201USMP | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ellacor | Cytrellis Biosystems, Inc. | 25 |
| Collagen P.I.N. | Induction Therapies, LLC | 9 |
| SkinPen Precision Elite | Bellus Medical, LLC | 4 |
| Exceed | Mt.derm GmbH | 4 |
| Safety Needle Cartridge 6-MNP 1.5 Exceed US | Mt.derm GmbH | 3 |
| SkinPen Precision Treatment Kits | Bellus Medical, LLC | 3 |
| CytoPen S2 | Emage Medical, LLC | 3 |
| Dp4 | Equipmed USA B.V. | 3 |
| PRO Pen Microneedling System | Dermalogica, LLC | 1 |
| Xcellarispro Twist Control unit | Dermaroller GmbH | 1 |
| Eclipse EVO Microneedling Cartridge | Eclipse, Inc. | 1 |
| Eclipse MicroPen EVO | Eclipse, Inc. | 1 |
Showing 12 of 43. All products under Powered Microneedle Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233709 | 2024-02-23 |
| K182407 | 2019-07-19 |
| K180778 | 2018-09-07 |
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.