(176 days)
No
The device description and performance studies focus on mechanical and electrical aspects, with no mention of AI, ML, image processing, or data analysis for decision-making.
Yes
The device is intended to be used as a "treatment to improve the appearance of facial acne scars," indicating a therapeutic purpose to address a medical condition (scars).
No
This device is described as a microneedling system intended to improve the appearance of facial acne scars, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it is a "minimally invasive microneedling device" comprised of physical components like a pen body, cartridge, power adapter, and sleeve, and describes mechanical actions. This indicates it is a hardware device, not software-only.
Based on the provided information, the Dr.pen Microneedling System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "improve the appearance of facial acne scars in adults aged 22 years and older." This is a therapeutic or cosmetic treatment applied directly to the skin, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device description clearly outlines a mechanical microneedling system that creates punctures in the skin. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Dr.pen Microneedling System does not fit this definition.
N/A
Intended Use / Indications for Use
The Dr.pen Microneedling 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 and older.
Product codes
OAI
Device Description
The Dr.pen Microneedling System is a minimally invasive 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 Dr. pen Microneedling System is comprised of a reusable pen body, a sterile, single use microneedling cartridge, a power adapter, and a disposible protective sleeve. 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 Dr.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
Prescription Use
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)
Performance Testing-Bench:
- A Motor Speed Puncture Rate Testing
- Needle Penetration Depth and Extension Accuracy Testing A
- Needle Bonding Strength Test
- A Use Life Testing
- A Cartridge Life Testing
- A Anti-suction Testing
- A Microbial Ingress Testing
Cleaning and Disinfection Validation:
- ISO 11737-1: 2018 (AAMI TIR-30; 2011; AAMI TIR-12:2004) Cleaning A Validation Intermediate-Level Disinfection Validation
Sterilization and Shelf Life:
- Ethylene oxide sterilization per ISO 11135-2014; ISO11737-1:2018; ISO A 11737-2: 2009; ISO 10993-7:2008
- A Sterilization, Shelf Life/Package Integrity in accordance with the following standards:
- · Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices medical devices ASTMF1980-16
- · Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection ASTM F1886/F1886M-16
- · Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration ASTM F1929-2015
- · Standard Test Method for Stripping Strength of Flexible Sealing Materials ASTM F88/F88M-2015
- · Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission ASTM D3078-02(2013)
- · Standard Test Methods For Internal Pressurization Failure Resistance Of Unrestrained Packages ASTM F1140-2013
- · Sterilization Sterile supply Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized DIN 58953-6:2016
- · Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process ISO 11737-2: 2019
Biocompatibility:
- Cytotoxicity (ISO 10993-5:2009);
- Sensitization and Irritation/Intracutaneous Reactivity (ISO 10993-10: 2010);
- Acute Systemic Toxicity (ISO 10993-11:2017);
- Material Mediated Pyrogenicity (ISO 10993-11:2017, USP 41 NF 36:2018, Pyrogen Test).
The results of these tests demonstrated the device to be biocompatible with no evidence of material mediated pyrogenicity.
Electrical Safety and Electromagnetic Compatibility:
- A 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.
Key results: The results of the performance testing described above demonstrate that Dr.pen Microneedling System is as safe and effective as SkinPen® Precision System [510K Number: DEN160029; submitted by Bellus Medical, LLC] supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
August 11, 2023
Guangzhou Ekai Electronic Technology Co., Ltd. % Helen Nan General Manager New Risen Enterprise Management Consulting Co., Ltd. Room 302, Building 3, Hangqian Mansion Hangqian Street, Lucheng District Wenzhou. Zhejiang 325000 China
Re: K230420
Trade/Device Name: Dr. pen Microneedling System Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device For Aesthetic Use Regulatory Class: Class II Product Code: OAI Dated: July 14, 2023 Received: July 14, 2023
Dear Helen Nan:
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 (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 located 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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, Digitally signed Mark by Mark Trumbore Trumbore - S Date: 2023.08.11 -5 08:02:17 -04'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230420
Device Name Dr.pen Microneedling System
Indications for Use (Describe)
The Dr.pen Microneedling 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 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) |
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Image /page/3/Picture/1 description: The image contains the logo for Guangzhou Ekai Electronic Technology Co., Ltd. The logo features a blue crescent shape on the left, followed by a square containing the text "Ekai" and smaller text "意机科技". To the right of this is the company name in Chinese characters, followed by the English translation "Guangzhou Ekai Electronic Technology Co., Ltd."
K230420_510(k) Summary (As required by 21 CFR 807.92(a))
1.0 Submitter Information
| Company: | Guangzhou Ekai Electronic Technology Co.,Ltd. |
|---|---|
| Address: | Third Floor, Building E, No.81 Zijing Road, Liwan |
| District, Guangzhou, Guangdong, CHINA | |
| Phone: | +86-20-81177539 |
| Contact Person: | Guihua Chen |
| Title: | CEO |
| Summary Prepared Date: | July 14th, 2023 |
2.0 Device Information
| Trade/Device Name: | Dr.pen Microneedling System |
|---|---|
| Model: | A20 |
| Device: | Powered Microneedle Device |
| Regulation Description: | Microneedling device for aesthetic use |
| Product Code: | QAI |
| Review Panel: | General & Plastic Surgery |
| Submission Type: | 510(k) |
| Regulation Number: | CFR 878.4430 |
| Device Class: | Class II |
3.0 Predicate Device and Reference Device Information
| Predicate Device: | |
|---|---|
| Trade/Device Name: | SkinPen® Precision System |
| K Number: | DEN160029 |
| Submitter: | Bellus Medical, LLC |
| Reference Device: | |
| Trade/Device Name: | MicroPen EVO™ |
| K Number: | K203144 |
| Submitter: | Eclipse MedCorp, LLC |
4.0 Device Description
The Dr.pen Microneedling System is a minimally invasive 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 Dr. pen Microneedling System is comprised of a reusable pen body, a sterile, single use microneedling cartridge, a power adapter, and a disposible protective sleeve. 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 Dr.pen pen body to the power adapter.
4
Image /page/4/Picture/1 description: The image contains the logo for Guangzhou Ekai Electronic Technology Co., Ltd. The logo features a blue crescent shape on the left, followed by the company name in both Chinese and English. The Chinese name is "广州意凯电子科技有限公司", and the English name is "Guangzhou Ekai Electronic Technology Co., Ltd.". There is also a smaller square logo with the text "Ekai" and "意机科技".
5.0 Indications for Use
The Dr.pen Microneedling 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 and older.
5
Image /page/5/Picture/1 description: The image contains the logo for Guangzhou Ekai Electronic Technology Co., Ltd. The logo features a stylized letter "C" shape in blue, with a square containing the text "Ekai" in orange. The full company name is written in both Chinese and English next to the logo. The English translation is "Guangzhou Ekai Electronic Technology Co., Ltd."
6.0 Comparison of Technological Characteristics with the Predicate Device
The Dr.pen Microneedling System has the identions for use as the predicate device and the same or equivalent technological features. A comparison of the subject and predicate device's technological features is presented in the following table.
| Property | Predicate Device | Reference Device | Subject Device | Comparison |
|---|---|---|---|---|
| Device Name | SkinPen® Precision System | MicroPen EVO™ | Dr.pen Microneedling System | - |
| 510(K) Number | DEN160029 | K203144 | K230420 | - |
| Classification name | Microneedling device for | |||
| aesthetic use | Microneedling device for | |||
| aesthetic use | Microneedling device for | |||
| aesthetic use | Same | |||
| Product Code | QAI | QAI | QAI | Same |
| Classification | Class II | Class II | Class II | Same |
| Regulation Number | 21 CFR 878.4430 | 21 CFR 878.4430 | 21 CFR 878.4430 | Same |
| Use | Prescription use | Prescription use | Prescription use | Same |
| Indications For Use | 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. | The Eclipse MicroPen EVO 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. | The Dr.pen Microneedling | |||
| 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 | |||
| Intended Location | ||||
| of Use | Face | Face | Face | Same |
| Power Source | ||||
| (Pen Body) | Rechargeable Li-ion battery | Rechargeable Li-ion battery | Rechargeable Li-ion battery | Same |
| Power Source | ||||
| (Battery Charger) | AC Powered | AC Powered | AC Powered | Same |
| Control | ||||
| Mechanism | Microprocessor; | |||
| embedded software | Microprocessor; | |||
| embedded software | Microprocessor; | |||
| embedded software | Same | |||
| Single Speed | ||||
| (RPM) | 6300 - 7700 | 6300 - 7700 | 6300 - 7700 | Same |
| Puncture Rate | 105 -128 stamps/second | 105 -128 stamps/second | 105 -128 stamps/second | Same |
| Microneedling | ||||
| Cartridge | Sterile, Single Use | Sterile, Single Use | Sterile, Single Use | Same |
| No. of Needles | 14 | 14 | 14 | Same |
| Needle Gauge | 34 Ga | 34 Ga | 34 Ga | Same |
| Needle Material | Stainless Steel | 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 | Straight, cylindrical body with a | |||
| conical tapered, sharp point | Same | |||
| Arrangement | Needles radially arranged | Needles radially arranged | Needles radially arranged | Discussion¹ |
| Needle Spacing | 2 mm spacing/3.54 mm² per | |||
| needle | 2 mm spacing/3.48 mm² per | |||
| needle | 2 mm spacing/3.96 mm² per | |||
| needle | Discussion² | |||
| Penetration Depth | 1.5 mm | |||
| (Recommended) | 1.5 mm | |||
| (Recommended) | 1.5 mm | |||
| (Recommended) | Same | |||
| Max. Needle | ||||
| Depth Setting | 2.5 mm | 2.00 mm | 2.0 mm | Discussion³ |
| Penetration | ||||
| Depth Selection | 11 depth settings; 0 mm to 2.5 | |||
| mm in 0.25 mm increments | 9 depth settings; 0 mm to 2.0 mm | |||
| in 0.25 mm increments | 9 depth settings; 0 mm to 2.0 mm | |||
| in 0.25 mm increments | Same | |||
| Sterility (cartridge) | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same |
| Shelf Life (cartridge) | 2 years | 2 years | 2 years | Same |
| Barrier: Cross/ | ||||
| Contamination | BioSheath | |||
| (Disposable) | MicroSleeve Sheath | |||
| (Disposable) | Protective Sleeve | |||
| (Disposable) | Same |
6
Image /page/6/Picture/1 description: The image shows the logo for Guangzhou Ekai Electronic Technology Co., Ltd. The logo features a blue arc on the left side, followed by a square containing the word "Ekai" in orange. To the right of the square, the company name is written in both Chinese and English. The English translation reads "Guangzhou Ekai Electronic Technology Co., Ltd."
7
Discussion': the reference device (Eclipse MicroPen EVO, K203114) has included to support that the subject device is the same as the reference device and state substantial equivalence to the a legally marketed device.
Discussion2: subject device has a slightly larger total surface area of the hub. No affect to geometry, puncture pattern, needle stamp.
Discussion3: not significant difference; treatment depth is 1.5 mm for both devices.
Substantial Equivalence:
Dr.pen Microneedling System is substantially equivalent to the Bellus Medical SkinPer® Precision System predicate device. The devices are under the same product code (QAI), both have the same indication for use, same number of needles, gauge, shape and arrangement, same material, recommended peneth, speed, puncture rate and sterilization method. The only technological differences are the maximum needle depth setting: the Dr.pen is 0.5 mm than the predicate (2.5 mm); and the penetration depth selection: the Dr.pen has 9 depth settings (0-2.0 mm increments) and the predicate device has 11 depth settings (0-2.5 mm in 0.25 mm increments). 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 surface area of the hub, however the needle spacing is the same (2 mm) and there is no effect on geometry, puncture pattern, These minor differences do not raise different questions of safety and effectiveness. Further, the results of performance testing support substantial equivalence of the Dr.per on to the predicate device.
8
Image /page/8/Picture/1 description: The image shows the logo for Guangzhou Ekai Electronic Technology Co., Ltd. The logo consists of a blue crescent shape on the left, followed by the company name in both English and Chinese. The English name is "Guangzhou Ekai Electronic Technology Co., Ltd." and the Chinese name is "广州意凯电子科技有限公司". There is also a square logo with the word "Ekai" in it.
7.0 Performance Testing-Bench
In combination with the general controls of the FD&C Act, the Dr.pen Microneedling System for aesthetic use has been subjected to performance testing and adheres to the following special controls and standards:
7.1 Bench Testing
- A Motor Speed Puncture Rate Testing
- Needle Penetration Depth and Extension Accuracy Testing A
-
Needle Bonding Strength Test
- A Use Life Testing
- A Cartridge Life Testing
- A Anti-suction Testing
- A Microbial Ingress Testing
7.2 Cleaning and Disinfection Validation
- ISO 11737-1: 2018 (AAMI TIR-30; 2011; AAMI TIR-12:2004) Cleaning A Validation Intermediate-Level Disinfection Validation
7.3 Sterilization and Shelf Life
- Ethylene oxide sterilization per ISO 11135-2014; ISO11737-1:2018; ISO A 11737-2: 2009; ISO 10993-7:2008
- A Sterilization, Shelf Life/Package Integrity in accordance with the following standards:
- · Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices medical devices ASTMF1980-16
- · Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection ASTM F1886/F1886M-16
- · Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration ASTM F1929-2015
- · Standard Test Method for Stripping Strength of Flexible Sealing Materials ASTM F88/F88M-2015
- · Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission ASTM D3078-02(2013)
- · Standard Test Methods For Internal Pressurization Failure Resistance Of Unrestrained Packages ASTM F1140-2013
- · Sterilization Sterile supply Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized DIN 58953-6:2016
- · Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process ISO 11737-2: 2019
8.0 Biocompatibilitv
The following tests were performed on the final, finished microneedling cartridge: Cytotoxicity (ISO 10993-5:2009); A
9
Image /page/9/Picture/1 description: The image shows a logo with a blue partial circle on the left side. Inside the circle is an orange square with the word "Ekai" written in black on the right side of the square. Below "Ekai" are two Chinese characters in black.
州意凯电子科技有限公
-
Sensitization and Irritation/Intracutaneous Reactivity (ISO 10993-10: 2010);
-
Acute Systemic Toxicity (ISO 10993-11:2017);
-
Material Mediated Pyrogenicity (ISO 10993-11:2017, USP 41 NF 36:2018, Pyrogen Test).
The results of these tests demonstrated the device to be biocompatible with no evidence of material mediated pyrogenicity.
10.0 Electrical Safety and Electromagnetic Compatibility
- A 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.
11.0 Statement of Substantial Equivalence
The results of the performance testing described above demonstrate that Dr.pen Microneedling System is as safe and effective as SkinPen® Precision System [510K Number: DEN160029; submitted by Bellus Medical, LLC] supports a determination of substantial equivalence.