510(k) K243143
K243143 is an FDA 510(k) premarket notification submitted by Bomtech Electronics Co., Ltd. for the device "E-PEN (E-PEN)". The FDA issued a decision of Substantially Equivalent on Apr 7, 2025. The device falls under product code QAI (Powered Microneedle Device), a Class II device regulated under 21 CFR 878.4430. Bomtech Electronics Co., Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 7, 2025
- Date Received
- Sep 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Powered Microneedle Device
- Device Class
- Class II
- Regulation Number
- 878.4430
- Review Panel
- SU
- Submission Type
- 510(k)
A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.