EPN - Needling Pen with electroporation
EPN - Needling Pen with electroporation
EPN - Needling Pen mit Elektroporation - Head
EPN - Needling Pen mit Elektroporation
EPN - Needling Pen with electroporation
EPN - Needling Pen with electroporation
EPN - Needling Pen mit Elektroporation - Head
EPN - Needling Pen mit Elektroporation

EPN - Needling Pen with electroporation

2-in-1 system: Motorised microneedling and electroporation in one device.

Individually adjustable: Needle depth from 0.0 to 2.0 mm, three motor speed levels and five electroporation levels.

Sterile single-use heads: Used with 9-pin 33G heads.

For suitable serums: Can be combined with cosmetic serums expressly intended by the manufacturer for microneedling and/or electroporation.

Class IIa medical device: For qualified professionals in accordance with the instructions for use.

Scope of delivery:
1x EPN Needling Pen
1x Hand strap
1x Power adapter
1x Protective cap
1x Instructions for use

100348
immediately available
€995.00
incl. tax, plus shipping Shipping excluded

 

Device for professional users

Microneedling and electroporation in one handpiece

The EPN Needling Pen combines motorised microneedling with electroporation. Needle depth (0.0 to 2.0 mm), motor speed (three levels) and electroporation (five levels) can be adjusted independently. The system uses sterile single-use heads with 9 electrode needles in 33G.

EPN Needling Pen
  • Microneedling and electroporation in one device Parameters can be adjusted independently
  • Needle depth Continuously adjustable from 0.0 to 2.0 mm
  • Motor / electroporation 3 motor levels / 5 electroporation levels

Medical device. For use by qualified professionals in accordance with the instructions for use. Needle heads are sterile single-use items and are not included with the device.

Two technologies, one device

The EPN system combines automated microneedling with electroporation. The following information is based on the instructions for use and the manufacturer's documentation.

Manufacturer illustration of automated microneedling Auto MTS
Manufacturer illustration of automated microneedling (Auto MTS)

Automated microneedling (Auto MTS)

  • Vertical stamping with motorised drive
  • Continuously adjustable needle depth from 0.0 to 2.0 mm
  • 9 electrode needles per sterile single-use head, 33G
  • Three speed levels: 4,000, 4,500 and 5,000
Manufacturer illustration of electroporation
Manufacturer illustration of electroporation

Electroporation

  • Electrical pulses designed to temporarily increase membrane permeability
  • Five intensity levels
  • Combined with the microneedling system in the same device

Quantitative claims regarding the uptake of active ingredients have deliberately not been included here. The manufacturer's brochure refers, among other sources, to preclinical data and published literature.

Manufacturer illustrations are schematic. The intended purpose, instructions for use and professional assessment remain authoritative.

Parameters from the manufacturer's protocol

The manufacturer's protocol specifies needle depths for facial and scalp applications. Select an area below to display the specified needle depth schematically.

Select a protocol entry.
Epidermis Dermis Subcutis Needle head 0.5 mm

Schematic cross-section, not to scale. The manufacturer's protocol specifies 1.0 mm for scalp microneedling alone and 0.5 mm for microneedling + EP. For facial applications, it specifies 1.0 mm for the cheek/nasolabial fold and 0.5 mm for other areas. Application protocol.

Controls A to E

Select a component to display its description below the illustration.

EPN Needling Pen controls
A · Needle head mount Mount for the sterile single-use needle head. Correct attachment should be checked before use in accordance with the instructions for use.
B · LCD display Displays microneedling speed, electroporation level and treatment time.
C · Control panel Used to select the operating mode and decrease or increase the selected level.
D · Start / Stop Starts or stops device operation.
E · Depth adjustment ring Continuously adjustable needle depth from 0.0 to 2.0 mm.

Needle head consumption calculator

One single-use head is discarded after each treatment. The calculator reads the current price of the 24-piece pack directly from the shop.

View EPN replacement heads

Regulatory status

Product type
Medical device, Class IIa
Manufacturer
Eunsung Global Corp., Wonju-si, Republic of Korea
MDD certificate
#0068/QCO-DM/070-2017 Rev. 04 · Directive 93/42/EEC
MDR transition
For qualifying Class IIa legacy devices, Article 120 MDR in conjunction with Regulation (EU) 2023/607 provides for a transitional period until 31 December 2028, provided that the applicable legal conditions continue to be fulfilled.
Responsible economic operator
KTR Europe GmbH, Eschborn, Germany

The specific legal marketability of the device depends on continued compliance with the applicable MDR transitional requirements and the current documentation issued by the manufacturer and notified body. The manufacturer's current documentation is authoritative.

Technical specifications

Type Electroporation Needle System (EPN)
Needle depth 0.0 to 2.0 mm
Speed 3 levels: 4,000 / 4,500 / 5,000
Electroporation 5 levels
Needle head 9 electrode needles, 33G, sterile, single use
Weight 95 g according to the instructions for use
Dimensions 27.85 (Ø) × 39.5 (D) × 186.5 (L) mm according to manufacturer documentation
Operating time 30 minutes of continuous operation according to manufacturer documentation
Reference 100348

Practical information

  • Use only by qualified professionals and in accordance with the instructions for use.
  • For needle depths above 1.0 mm, the manual specifically identifies qualified healthcare professionals as the intended users.
  • Do not reuse or resterilise sterile single-use needle heads.
  • Observe the contraindications, warnings, hygiene requirements and aftercare instructions contained in the current instructions for use.
  • When using active ingredients, only use products whose intended application covers the respective device-assisted procedure.

Downloads

Frequently asked questions

Which needle heads are used with the EPN?

The manual specifies a sterile single-use head with 9 electrode needles in 33G. The heads are individually packaged, with 24 pieces per box.

What needle depth can be selected?

The device can be adjusted from 0.0 to 2.0 mm. The manufacturer's protocol specifies parameters for facial and scalp applications; these are shown separately above.

How many speed and electroporation levels are available?

The device has three microneedling speed levels and five electroporation levels.

How should the device be cleaned?

Cleaning must be performed in accordance with the current instructions for use. The needle head is sterile and intended for single use only.

Are needle heads included with the device?

No. The manual lists the EP Multi Needle as a separately available accessory.

For professional users: This product information does not replace the instructions for use or professional assessment. Medical applications and specific parameters must be assessed on the basis of the current manufacturer documentation and the user's professional qualifications.

Features

GPSR – General Product Safety Regulation

Responsible Economic Operator according to GPSR:

KTR Europe GmbH

Mergenthalerallee 77
65760 Eschborn, German

Tel: +49(0)6196-887170

E-Mail: [email protected]

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