SkinPen Precision System

K220506 · Crown Aesthetics · QAI · Mar 7, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220506
• Device Name: SkinPen Precision System
• Applicant: Crown Aesthetics
• Product Code: QAI · General, Plastic Surgery
• Decision Date: Mar 7, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4430
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.

Device Story

SkinPen® Precision System is a microneedling device used in clinical settings by trained healthcare professionals. The system comprises a motorized handpiece and a sterile, disposable 14-needle cartridge. The device creates controlled micro-injuries in the skin to improve the appearance of facial acne scars and neck wrinkles. The handpiece is protected during use by a disposable BioSheath to prevent contamination. Between patient uses, the device is sanitized using Sani-Cloth AF3. The system includes a hydrogel wound dressing (Lift HG) for post-procedure application to protect skin and prevent drying. The device operates at 6300–7700 RPM with adjustable needle protrusion (0–2.5 mm).

Clinical Evidence

No clinical testing was conducted for this submission. Bench testing was performed to validate the efficacy of the Sani-Cloth AF3 for device disinfection under worst-case microbial contamination scenarios.

Technological Characteristics

Microneedling handpiece with 14 solid medical-grade stainless steel needles. Adjustable needle protrusion (0–2.5 mm). Frequency: 6300–7700 RPM (105–128.3 Hz). Accessories include sterile disposable needle cartridges, BioSheath, and Lift HG hydrogel. Sanitization via Sani-Cloth AF3.

Indications for Use

Indicated for adults aged 22+ with facial acne scars (all Fitzpatrick skin types) and neck wrinkles (Fitzpatrick skin types II-IV).

Regulatory Classification

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.

Special Controls

The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate. 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. Performance data must demonstrate the sterility of the patient-contacting components of the device. Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life. Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device. Software verification, validation, and hazard analysis must be performed for all software components of the device. The patient-contacting components of the device must be demonstrated to be biocompatible. Performance data must validate the cleaning and disinfection instructions for reusable components of the device. 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) Shelf life. 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) Post-operative care instructions.

*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.

Predicate Devices

• SkinPen Precision System (K202243)

Submission Summary (Full Text)

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March 7, 2022

Crown Aesthetics Marie Fogartie Director of Regulatory Affairs 5005 Lyndon B. Johnson Freeway, Suite 370 Dallas. Texas 75244

Re: K220506

Trade/Device Name: SkinPen®Precision System Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device for Aesthetic Use Regulatory Class: Class II Product Code: QAI Dated: February 18, 2022 Received: February 22, 2022

Dear Marie Fogartie:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements,

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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 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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations. please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K220506

Device Name SkinPen® Precision System

Indications for Use (Describe)

The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <span style="font-size: large;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: large;">☐</span> Over The Counter Use (21 CFR 801 Subpart C) |

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared: March 2, 2022

- 1. Submitter and Owner:
Crown Aesthetics 5005 Lyndon B. JohnsonFreeway Suite 370 Dallas, Texas 75244, USA

- 2. Official Correspondent:
Marie Fogartie, Director of Regulatory Affairs Phone: [phone] Email: [e-mail]

- 3. Submission Type: Special 510(k)
- Proprietary Name: SkinPen® Precision System 4.
- 5. Device Classification Information:

Classification Name: Microneedling Device for Aesthetic Use Requlation Number: 878.4430 Product Code: QAI Device Class: 2

- 6. Predicate Device: K202243 SkinPen Precision System
- 7. Device Description:

The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen® Precision) and a sterile needle cartridge (SkinPen® Precision Cartridge).

The accessories are a charging base and a BioSheath. A SkinPen® Precision System treatment kit is provided separately and contains the following:

- SkinPen® Precision Cartridge: sterile, disposable needle cartridge. Not ● to be resterilized or reused. (K202243, Class 2, Regulation 878.4430, Product Code: QAI.)
- Lift HG: hydrogel wound dressing (without drugs and/or biologics), to ● protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure. (Class I, 510(k) Exempt, Regulation 878.4022, Product code: NAE.)
- SkinPen® BioSheath: nonsterile, disposable cover for the ● microneedling pen handpiece to avoid contamination of the SkinPen® Precision.
- . Sani-Cloth AF3: Sanitizing cloth available for purchase along with device to sanitize between uses.

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- 8. Indications/Intended use:
The SkinPen® Precision system is a microneedling device and accessories intendedto be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.

- 9. Indications for Use Comparison:
The subject and the predicate device (K202243) have identical indications for use statements.

| Characteristic | Subject Device | Predicate Device<br>K202243 | Comparison |
|----------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|------------|
| Trade Name | SkinPen® Precision System | SkinPen® Precision System | Same |
| Classification<br>Name | Microneedling device<br>foraesthetic use | Microneedling device<br>foraesthetic use | Same |
| Classification | 2 | 2 | Same |
| Product Code | QAI | QAI | Same |
| Requlation No. | 878.4430 | 878.4430 | Same |
| Prescription<br>Use | Yes | Yes | Same |
| Target<br>Population | Adults age 22 and over | Adults age 22 and over | Same |
| Target User | Healthcare professionals<br>trained in use of the device | Healthcare professionals<br>trained in use of the device | Same |
| Environment | Clinical | Clinical | Same |
| Treatment Area | Face | Face | Same |
| Shape of needle<br>cartridge | Round | Round | Same |
| Needles | 14 total solid medical grade<br>stainless steel | 14 total solid medical grade<br>stainless steel | Same |
| Needle<br>Protrusion<br>settings | 0–2.5 mm | 0–2.5 mm | Same |
| Max. Needle<br>Length used inthe<br>clinical study | 2.5mm | 2.5mm | Same |
| Frequency | 6300 RPM to 7700 RPM<br>(105-128.3 Hz) | 6300 RPM to 7700 RPM<br>(105-128.3 Hz) | Same |

- 10. Technological characteristics comparison:
The subject device is identical to the predicate device, except the use of a different disinfecting cloth. The cleaning validation described below demonstrated the device modification raises no safety or effectiveness concerns.

## 11. Non-clinical performance testing

Cleaning validation testing was conducted for the disinfecting cloth that is the subject of this submission. The cleaning test applied bacteria to the device after being wiped clean with a Sani-Cloth AF3. After applying the bacteria, the devicewas cleaned again with the Sani-Cloth AF3. After application of bacteria on the SkinPen device surface under worst-case conditions of no bio-sheath,

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and a minimal cleaning time of 1 minute, it was confirmed that the bacteria were removedfrom the device when cleaned with Sani-Cloth AF3. In conclusion, even if the device is contaminated by bacteria, Sani-Cloth AF3 is considered sufficient for bacterial removal from the device, as the number of bacteria applied to the device was sufficiently high enough to simulate a worst-case scenario of possible microbial contamination. The new Sani-Cloth AF3 shows the same or improved results than the previously used Sani-Cloth HB.

- 12. Clinical Testing Summary
No Clinical testing was conducted as part of this submission.

- 13. Statement of Substantial Equivalence:
Crown Aesthetics has demonstrated that the SkinPen® Precision System has the same device classification, same intended use and technological characteristics as the predicate device. The only change in this submission is the cloth used for disinfection is shown effective in a validation report provided with this application.