Dr.Pen
Catalogue number A20, listed by Guangzhou Ekai Electronic Technology Co., Ltd., China, under Powered Microneedle Device. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Guangzhou Ekai Electronic Technology Co., Ltd., China |
|---|---|
| FDA product code | QAI |
| Device type | Powered Microneedle Device |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4430 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2024-08-06 |
| Record revised | 2026-01-01 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Distribution end date | 2026-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A20 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ellacor | Cytrellis Biosystems, Inc. | 25 |
| Collagen P.I.N. | Induction Therapies, LLC | 9 |
| Footswitch | Mt.derm GmbH | 5 |
| 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 |
Showing 12 of 43. All products under Powered Microneedle Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230420 | 2023-08-11 |
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.