E-Pen Powered Microneedle Device
by Bomtech Electronics Co., Ltd. EUDAMED510(k)
Active
510(k) K243143
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK243143 | Date7 Apr 2025 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- E-Pen (E-Pen)
- 510(k) Number
- FDA Product Code
- QAI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4430
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The E-Pen is a Powered Microneedle Device, designed to deliver precise, controlled microneedle treatments for dermatological and cosmetic applications. It employs a motorised mechanism to drive microneedles into the skin, facilitating procedures such as collagen induction, exfoliation, or targeted drug delivery without full-thickness penetration.
Supplied as a single-use, non-sterile device, the E-Pen is intended for use in clinical settings such as dermatology clinics or plastic surgery offices. It operates under FDA 510(k) clearance and MDD compliance, with a classification as a Class II medical device (OpenFDA: 878.4430). Multiple registration numbers (e.g., 3007645866) reflect its authorised variants, though no specific MRI safety or reusable components are indicated.
Other devices from Bomtech Electronics Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
What types of dermatological procedures can the E-Pen be used for, and how does it differ from traditional microneedling methods?
The E-Pen is designed for procedures like collagen induction, exfoliation, and targeted drug delivery without causing full-thickness skin penetration. Unlike traditional manual microneedling, it uses a motorized mechanism to drive microneedles into the skin with precise, controlled depth, reducing user variability and improving consistency in treatments.
Is the E-Pen intended for single-use only, and if so, what does this mean for clinical workflows?
Yes, the E-Pen is supplied as a single-use, non-sterile device. This means each unit is intended for one patient only, minimizing cross-contamination risks. Clinics must dispose of it after use and prepare a new unit for subsequent patients, ensuring compliance with infection control protocols.
What regulatory pathways has the E-Pen followed, and how does this affect its use in clinical settings?
The E-Pen has undergone FDA 510(k) clearance and complies with the Medical Device Directive (MDD), classifying it as a Class II device under OpenFDA category 878.4430. This means it has been evaluated for safety and effectiveness by regulatory authorities, allowing its use in clinical settings like dermatology clinics and plastic surgery offices under approved conditions.
Are there different models or sizes available for the E-Pen, and how might this affect treatment selection?
The E-Pen comes in multiple authorized variants, as indicated by its registration numbers (e.g., 3007645866). While specific sizes or models aren’t detailed in the data, these variants likely cater to different clinical needs, such as varying needle depths or treatment areas. Clinicians should consult the manufacturer’s documentation to select the appropriate variant for their intended procedure.
How should the E-Pen be stored, and are there any special considerations for its non-sterile status?
Since the E-Pen is non-sterile and single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until use to prevent contamination. Clinics must follow standard medical device storage guidelines to ensure usability and safety before opening the device.