(189 days)
Not Found
No.
The document describes a microneedling device that mechanically creates punctures in the skin. There is no mention of AI, machine learning, or any form of intelligent processing within the device's functionality. The "Software validation test" mentioned is for general embedded software, common in many medical devices, and does not imply AI.
Yes
The device is intended to be used as a treatment to improve the appearance of facial acne scars, which directly addresses a medical condition or physical state.
No
The device is described as a microneedling device intended to improve the appearance of facial acne scars, which is a treatment rather than a diagnostic function.
No
The device is a physical microneedling device with electrical and mechanical components. It explicitly describes hardware components such as a reusable pen body, a sterile, single-use microneedling cartridge, and a power adapter. While it mentions software validation, this is for the control of the physical device, not the device itself being purely software. The summary also details extensive hardware-related testing like biocompatibility, sterilization validation, EMC, and electrical safety tests, which are not relevant for a software-only medical device.
No.
An IVD is a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The E-PEN is a microneedling device used to improve the appearance of acne scars by mechanically creating punctures in the skin, which is a direct treatment, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
QAI
Device Description
The E-PEN is a microneedling device that mechanically creates microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The E-PEN is comprised of a reusable pen body, a sterile, single use microneedling cartridge, and a power adapter. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending on the condition of the skin being treated. Charging is accomplished by attaching the E-PEN pen body to the power adapter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
adults aged 22 years and older.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Biocompatibility Testing: In accordance with ISO 10993-1, the subject device is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (Medical devices -Bacterial Endotoxin and pyrogen test, USP Bacterial endotoxins test. Package integrity testing, after environmental conditioning and simulated transportation using ASTM D4169-22, was conducted on final packaged, and sterile devices. All packaging is acceptable for protection of final finished product and sterility maintenance. Sterile Barrier Packaging Testing performed on the proposed device includes Seal peel test – ASTM F88/F88 -15 and Dye migration- ASTM F1929-15. Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier System for Medical Devices.
- EMC & Electrical safety test: IEC-60601-1:2005+A1:2012 – Medical electrical equipment–Part 1: General Requirements for Basic Safety and Essential Performance; EN/IEC 60601-1-2: 2015 /IEC 60601-1-2: 2014–Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirement and tests
- Software validation test: The level of concern of the software of the E-PEN is moderate and the software validation tests were performed.
- Bench Test: Needle Length, Needle Penetration Depth, Single Speed (RPM), Preventing of the re-use needle cartridge.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4430 Microneedling device for aesthetic use.
(a)
Identification. A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate.
(2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Accuracy of needle penetration depth and puncture rate;
(ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and
(iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
(5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device.
(6) Software verification, validation, and hazard analysis must be performed for all software components of the device.
(7) The patient-contacting components of the device must be demonstrated to be biocompatible.
(8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device.
(9) Labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate;
(iii) Validated methods and instructions for reprocessing of any reusable components;
(iv) Disposal instructions; and
(v) A shelf life.
(10) Patient labeling must be provided and must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) The probable risks and benefits associated with use of the device; and
(iii) Postoperative care instructions.
FDA 510(k) Clearance Letter - E-pen Microneedling Device
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 7, 2025
Bomtech Electronics Co., Ltd.
℅ Seo Juntaek
President
Corazon
20, Jukjeon-ro, Giheung-gu, Gyeonggi-do
Yongin, 16897
Korea, South
Re: K243143
Trade/Device Name: E-pen (e-pen)
Regulation Number: 21 CFR 878.4430
Regulation Name: Microneedling Device For Aesthetic Use
Regulatory Class: Class II
Product Code: QAI
Dated: February 28, 2025
Received: February 28, 2025
Dear Seo Juntaek:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
April 7, 2025
Bomtech Electronics Co., Ltd.
℅ Seo Juntaek
President
Corazon
20, Jukjeon-ro, Giheung-gu, Gyeonggi-do
Yongin, 16897
Korea, South
Re: K243143
Trade/Device Name: E-pen (e-pen)
Regulation Number: 21 CFR 878.4430
Regulation Name: Microneedling Device For Aesthetic Use
Regulatory Class: Class II
Product Code: QAI
Dated: February 28, 2025
Received: February 28, 2025
Dear Seo Juntaek:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K243143 - Seo Juntaek Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K243143 - Seo Juntaek Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Wilmarie Flores -S
For Tek Lamichhane, Ph.D.
Assistant Director
DHT4B: Division of Plastic and
Reconstructive Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K243143
Device Name
E-PEN
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
E-PEN Traditional 510(k)
510(k) Summary
I. Submitter
510(k) Submitter: BOMTECH ELECTRONICS CO., LTD.
322, Gonghang-daero, Gangseo-gu, Seoul, Republic of Korea
Phone: +82 2 523 8295
Primary Contact: Juntaek Seo
info@corazon.kr
Alternate Contact: Junseok Lee
RA manager
bomtech@bomtech.net
Date prepared: 08, September, 2024
II. Device Name
Device Trade Name: E-PEN
Common Name: Powered Microneedle Device
Regulation Number: 21 CFR 878.4430
Regulatory Class: Class II
Product Code: QAI
III. Legally Marketed Predicate Device
Predicate #: DEN160029
Predicate Trade Name: SkinPen Precision System
IV. Device Description
The E-PEN is a microneedling device that mechanically creates microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The E-PEN is comprised of a reusable pen body, a sterile, single use microneedling cartridge, and a power adapter. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending on the condition of the skin being
Page 1 / 5
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E-PEN Traditional 510(k) Page 2 / 5
treated. Charging is accomplished by attaching the E-PEN pen body to the power adapter.
V. Indications for Use
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.
VI. Comparison of technological characteristics with the predicate device
The E-PEN is substantially equivalent to the following predicate device:
Primary Predicates: For Indication for Use and Technological Characteristics:
- DEN160029, SkinPen Precision System
| Item | E-PEN | SKINPEN PRECISION SYSTEM | Remark |
|---|---|---|---|
| 510(k) Number | - | DEN160029 | - |
| Manufacturer | Bomtech Electronics Co., Ltd. | Bellus Medical, LLC | - |
| Regulation Number No. | 21 CFR 878.4430 | 21 CFR 878.4430 | Same |
| Product Code | QAI | QAI | Same |
| Indications for Use | 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. | SkinPen Precision System 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 or older. | Same |
| Prescription or OTC | Prescription | Prescription | Same |
| Intended Location of Use | Face | Face | Same |
| Power Source (Pen Body) | Rechargeable Li-ion battery | Rechargeable Li-ion battery | Same |
| Power Source (Battery Charger) | AC Powered | AC Powered | Same |
| Control Mechanism | Microprocessor; Embedded software | Microprocessor; Embedded software | Same |
| Single Speed (RPM) | 6,300~7,700 | 6,300~7,700 | Same |
| Puncture Rate | 105~128 stamps/second | 105~128 stamps/second | Same |
| Microneedling Cartridge | Sterile, Single Use | Sterile, Single Use | Same |
| No. of Needles | 14 | 14 | Same |
| Needle Gauge | 34 G | 34 G | Same |
| Needle material | Stainless Steel | Stainless Steel | Same |
| Needle Shape Geometry | Straight, cylindrical body with a conical tapered, sharp point | Straight, cylindrical body with a conical tapered, sharp point | Same |
| Arrangement | Needles radially arranged | Needles radially arranged | Same |
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E-PEN Traditional 510(k) Page 3 / 5
| Item | E-PEN | SKINPEN PRECISION SYSTEM | Remark |
|---|---|---|---|
| Needle Spacing | 2 mm spacing/3.18 mm² per needle | 2 mm spacing/3.54 mm² per needle | Similar (Note 1) |
| Penetration Depth | 1.5 mm (Recommended) | 1.5 mm (Recommended) | Same |
| Max. Needle Depth Setting | 2.00 mm | 2.5 mm | Similar (Note 2) |
| Sterility (Cartridge) | Ethylene Oxide | Ethylene Oxide | Same |
Note 1: Needle Spacing
Subject device has a slightly smaller total surface area of the hub. No affect to geometry, puncture pattern, needle stamp.
Note 2: Max. Needle Depth Setting
Not significant difference; treatment depth is 1.5mm for both devices.
E-PEN is substantially equivalent to the Bellus Medical SkinPen® Precision System predicate device. The devices are under the same product code (QAI), both have the same intended use/ indication for use, same number of needles, gauge, shape and arrangement, same material, recommended penetration depth, speed, puncture rate and sterilization method. The only technological differences are the maximum needle depth setting: the E-PEN is 0.5 mm shorter (2.0 mm) than the predicate (2.5 mm); These differences are minor and are not significant since both devices recommend the same treatment depth (1.5 mm). There is a small and insignificant difference between the subject and predicate in total surface area of the hub, however the needle spacing is the same (2 mm) and there is no effect on geometry, puncture pattern, needle stamp. These minor differences do not raise different questions of safety and effectiveness. Further, the results of performance testing support substantial equivalence of the E-PEN to the predicate device. Safety and effectiveness for needle depth settings greater than 1.5 mm has not been evaluated. The E-PEN allows for incremental increase in settings of up to 2.5mm to allow for the variability in thickness of healthy skin and acne scar tissue. However, the device has not been clinically evaluated at cartridge settings of greater than 1.5mm. As there are fine structures (i.e., nerve branches and accompanying blood vessels) that run under the skin and are essential to proper tissue function, it is not recommended to treat at needle depths greater than 1.5mm. This precaution can also be found in the "Precautions before use" section of the user manual provided by Bomtech Electronics.
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E-PEN Traditional 510(k) Page 4 / 5
VII. Performance data
1. Biocompatibility Testing
In accordance with ISO 10993-1 the subject device is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (Medical devices -Bacterial Endotoxin and pyrogen test, USP Bacterial endotoxins test.
- Package integrity testing, after environmental conditioning and simulated transportation using ASTM D4169-22, was conducted on final packaged, and sterile devices. All packaging is acceptable for protection of final finished product and sterility maintenance.
- Sterile Barrier Packaging Testing performed on the proposed device:
- Seal peel test – ASTM F88/F88 -15
- Dye migration- ASTM F1929-15
- Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier System for Medical Devices.
4. EMC & Electrical safety test
- IEC-60601-1:2005+A1:2012 – Medical electrical equipment–Part 1: General Requirements for Basic Safety and Essential Performance;
- EN/IEC 60601-1-2: 2015 /IEC 60601-1-2: 2014–Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirement and tests
Page 4 / 5
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E-PEN Traditional 510(k) Page 5 / 5
5. Software validation test
The level of concern of the software of the E-PEN is moderate and the software validation tests were performed.
6. Bench Test
- Needle Length
- Needle Penetration Depth
- Single Speed (RPM)
- Preventing of the re-use needle cartridge
VIII. Conclusion
The results of the performance testing described above demonstrate that E-PEN is as safe and effective as SkinPen Precision System (DEN160029) supports a determination of substantial equivalence.
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