E-PEN
E-Pen is a microneedling device for improving the appearance of facial acne scars in adults aged 22 years or older. A reusable powered pen drives a sterile, single-use cartridge to make…
E-Pen is a microneedling device for improving the appearance of facial acne scars in adults aged 22 years or older. A reusable powered pen drives a sterile, single-use cartridge to make microscopic punctures in the epidermis and dermis.
The cartridge contains 14 radially arranged stainless-steel needles. Needle depth is user-adjustable up to a 2.0 mm setting, with 1.5 mm recommended penetration, and the device operates at 105 to 128 stamps per second.
Listed Item
The E-PEN is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.
Power and Cartridge
A rechargeable lithium-ion battery powers the pen, with an external adapter used for charging. The cartridge is ethylene-oxide sterilized and replaced after use; the pen body is reused.
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 | Bomtech Electronics Co., Ltd., South Korea |
|---|---|
| FDA product code | QAI |
| Device type | Powered Microneedle Device |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4430 |
| Establishment | Manufacturer |
| 510(k) | K243143 |
| Record published | 2026-04-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Powered Microneedle Device | In distribution |
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 |
|---|---|
| K243143 | 2025-04-07 |
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.