The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.

Device Description

The SER Pen Carain MicroSystem is a handheld powered microneedling device consisting of a rechargeable motorized handpiece and disposable, single-use needle cartridges (12-pin and 36-pin). Microneedles are made of surgical-grade stainless steel (304) and are gamma sterilized.

Design modifications include:

Addition of a powered 7-speed control head (6,200–9,000 RPM) with direct corded power option.
Modified disposable cartridge (Model T2.0), shortened by 7 mm, with protective cap and compensatory spring.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - SER Pen Carain MicroSystem

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

October 29, 2025

Su-Ko Technologies LLC
℅ Marc Sanchez
Regulatory Counsel
Contract In-House Counsel and Consultants, LLC d/b/a FDA Att
1717 Pennsylvania Ave NW
Suite 1025
Washington, District of Columbia 20006

Re: K253153
Trade/Device Name: SER Pen Carain MicroSystem (MP1209SP)
Regulation Number: 21 CFR 878.4430
Regulation Name: Microneedling device for aesthetic use
Regulatory Class: Class II
Product Code: QAI
Dated: September 24, 2025
Received: September 26, 2025

Dear Marc Sanchez:

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.

Page 2

K253153 - Marc Sanchez
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

K253153 - Marc Sanchez
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 Digitally signed by Wilmarie Flores -S

For Jodie Giordano, 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)
K253153

Device Name
SER Pen Carain MicroSystem (MP1209SP)

Indications for Use (Describe)
The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or 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

Special 510(k) Summary K253153

SER Pen Carain MicroSystem (Model MP1209SP)

1. Submitter Information

Sponsor: Su-Ko Technologies, LLC
7801 N Lamar Blvd, Suite F34
Austin, TX 78752

Manufacturer: Guangzhou Carain Beauty Equipment Co., Ltd
Room 901-1, Blvd. No. 8 of CIMC High-Tech Manufacturing Center
Chencun Town, Shunde District, Foshan City, Guangdong, China 528313

Contact Person: Marc C. Sanchez, Esq.
Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty)
1717 Pennsylvania Ave NW, Suite 1025
Washington, DC 20006
Tel: 202-765-4491
Email: msanchez@fdaatty.com

2. Device Identification

Proprietary Name: SER Pen Carain MicroSystem (Model MP1209SP)
Common Name: Powered Microneedle Device
Regulation Number: 21 CFR 882.4810
Regulatory Class: Class II
Product Code: QAI
Submission Type: Special 510(k) (Design Modification)
510(k): K253153
Date: October 28, 2025

3. Predicate Devices

Primary Predicate: SER Pen Carain MicroSystem (K241355)

The subject device is substantially equivalent to the cleared SER Pen Carain MicroSystem (K241355) with modifications as described.

4. Device Description

Design modifications include:

Addition of a powered 7-speed control head (6,200–9,000 RPM) with direct corded power option.
Modified disposable cartridge (Model T2.0), shortened by 7 mm, with protective cap and compensatory spring.

Page 1 of 2

Page 6

No changes were made to the intended use, indications for use, or fundamental technology.

5. Indications for Use

The SER Pen Carain MicroSystem is intended to be used as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I–III, and to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years and older.

There are no changes to the indications for use.

6. Summary of Technological Characteristics

The modified device has the same fundamental scientific technology as the predicate device:

Mode of Action: Microneedling using reciprocating stainless steel needles.
Energy Source: Rechargeable DC motor (5V, 1A).
Maximum Penetration Depth: 2.5 mm.
Needle Arrays: 12-pin or 36-pin.

The design modifications (7-speed control head, cartridge T2.0) do not alter these characteristics.

7. Performance Data

Verification and validation testing was conducted to confirm safety and performance:

Electrical Safety & EMC: IEC 60601-1, 60601-1-2 (PASS).
Mechanical Durability: Control head and cartridge T2.0 (PASS).
Depth Penetration: Accuracy within ±0.25 mm, 98.9% passing (PASS).
Reciprocation Testing: RPM within ±5% (air) and ±10% (substrate) (PASS).
Biocompatibility: Needles unchanged; ISO 10993 compliance (PASS).
Sterilization: Gamma irradiation validated (PASS).

Results confirm the device modifications do not raise new safety and effectiveness questions.

8. Conclusion

The SER Pen Carain MicroSystem with design modifications (powered 7-speed control head and cartridge T2.0) is substantially equivalent to the predicate device (K241355). The modifications do not raise new questions of safety or effectiveness.

Page 2 of 2

Regulation Number and Section

§ 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.