Device
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.
Manufacturer
BOMTECH ELECTRONICS CO., LTD.
BOMTECH ELECTRONICS CO., LTD.
Model: Powered Microneedle Device
DI: 08800016000443
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9ff78c1b-0471-4017-8e74-ca4871db5516
Distribution Status:
In Commercial Distribution
DUNS Number:
690464958
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08800016000443
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61216
Name: Cosmetic micro-needling electronic handpiece, professional
Definition:
A hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device.
FDA Product Codes
QAI
Powered Microneedle Device
Premarket Submissions
Submission Number:
K243143
Supplement Number:
000