SkinPen Precision System

K202243 · Crown Aesthetics · QAI · Apr 2, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202243
• Device Name: SkinPen Precision System
• Applicant: Crown Aesthetics
• Product Code: QAI · General, Plastic Surgery
• Decision Date: Apr 2, 2021
• Decision: SESE
• Submission Type: Traditional
• 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 consisting of a motorized handpiece and sterile, disposable needle cartridges. It uses 14 medical-grade stainless steel needles to create controlled micro-injuries in the skin. Operated by trained healthcare professionals in clinical settings, the device is used with a hydrogel (Skinfuse Lift HG) to reduce friction. The procedure is intended to improve the appearance of neck wrinkles and facial acne scars. The device is powered by an electric motor (6300-7700 RPM). Clinical benefits include improved aesthetic appearance of skin texture and wrinkles, as reported by clinicians and patients. The system includes a charging base and a disposable BioSheath to prevent handpiece contamination.

Clinical Evidence

Single-center prospective study of 35 subjects (32 analyzed) aged 44-65. Primary endpoint: G. Lemperle Wrinkle Scale for neck wrinkles at 3 months post-treatment. Results showed mean improvement from 3.31 (baseline) to 2.45 (3 months), with 50% of subjects achieving ≥1 grade improvement. Secondary endpoints included Clinician's Global Aesthetic Improvement Scale (CGAIS) and Subject GAIS. No device-related adverse events reported; common side effects included transient redness, dryness, peeling, and tenderness.

Technological Characteristics

Microneedling device; 14 medical-grade stainless steel needles; 0-2.5 mm protrusion; 6300-7700 RPM (105-128.3 Hz) frequency. Includes sterile disposable cartridges and non-sterile BioSheath. Clinical environment use. Class II, Product Code QAI, Regulation 878.4430.

Indications for Use

Indicated for treatment to improve appearance of neck wrinkles (Fitzpatrick II-IV) and facial acne scars in adults aged 22+ (all Fitzpatrick types).

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

• Exceed Microneedling Device (K180778)

Reference Devices

• SkinPen® Precision System (DEN160029)

Submission Summary (Full Text)

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April 2, 2021

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

# Re: K202243

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 4, 2021 Received: February 5, 2021

# 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, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Lixin Liu. Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic 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) K202243

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) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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

- 3. Submission Type: Traditional 510(k)
- 4. Proprietary Name: SkinPen® Precision System
- 5. Device Classification Information: Classification Name: Microneedling Device for Aesthetic Use Regulation Number: 878.4430 Product Code: QAI Device Class: 2
- 6. Predicate Device: K180778 Exceed Microneedling Device Reference Device: DEN 160029 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. (DEN160029, 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.
- 8. Indications/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.

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## 9. Indications for Use Comparison:

| | Subject Device | Predicate Device |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K202243 | K180778 |
| Indication for<br>Use | The SkinPen® Precision system is a<br>microneedling device and accessories<br>intended to be used as a treatment to<br>improve the appearance of wrinkles of<br>the neck for Fitzpatrick skin types II -<br>IV and to improve the appearance of<br>facial acne scars in adults with all<br>Fitzpatrick skin types aged 22 years<br>and older. | The Exceed is a microneedling<br>device and accessories is intended<br>for the treatment of wrinkles in<br>Fitzpatrick skintypes I, II and/or<br>III in the following facial areas:<br>glabellar frown lines, periorbital<br>lines and cheek folds in adults<br>aged 22 years or older |

## 10. Technological characteristics comparison:

| Characteristic | Subject Device<br>K202243 | Predicate Device<br>K180778 |
|-----------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------|
| Trade Name | SkinPen® Precision System | Exceed Microneedling device |
| Classification<br>Name | Microneedling device for aesthetic<br>use | Microneedling device for aesthetic<br>use |
| Classification | 2 | 2 |
| Product Code | QAI | QAI |
| Regulation No. | 878.4430 | 878.4430 |
| Prescription Use | Yes | Yes |
| Target Population | Adults age 22 and over | Adults age 22 and over |
| Target User | Healthcare professionals trained in<br>use of the device | Healthcare professionals trained in<br>use of the device |
| Environment | Clinical | Clinical |
| Treatment Area | Face and Neck | Face |
| Shape of needle<br>cartridge | Round | Squared |
| Needles | 14 total solid medical grade<br>stainless steel | 6 needles, squared arrangement<br>medical grade stainless steel |
| Needle Protrusion<br>settings | 0—2.5 mm | 0 - 1.9 mm |
| Max. Needle<br>Length used in the<br>clinical study | 2.5 mm | 1.5 mm |
| Frequency | 6300 RPM to 7700 RPM (105-<br>128.3 Hz) | 6300 RPM to 7700 RPM (100-150<br>Hz) |

## 11. Non-clinical performance testing

The SkinPen® Precision is subject to the Special Controls listed in 21 CFR 878.4430(b). A new, additional cleaning and disinfection method has been validated and is contained within the instructions for use, however no other changes have been made to the technological characteristics of the device since DEN160029. The differences in technological characteristics between the subject and predicate device, including needle count, configuration, and maximum protrusion settings, did not necessitate additional non-clinical testing as compliance to the Special Controls was previously demonstrated in DEN160029.

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## 12. Clinical Testing Summary

A clinical study was conducted to support the safety and effectiveness of the SkinPen Precision System for the treatment of acne scars on the face in DEN160029.

A clinical study has since been conducted to support the safety and effectiveness of the SkinPen Precision System for the treatment of wrinkles on the neck.

The single center study was conducted on a total of 35 subjects (2 male and 33 female), aged 44 years and older from various ethnic groups with multiple skin tones (pale to dark skin). Treatments were given on day 1, day 30, day 60, and day 90 with follow-up visits at 1 month and 3 months after the last treatment. Under direct supervision of a licensed Physician, treatments were conducted by a trained aesthetician (skin care specialist). The face and neck were cleaned and numbed prior to treatment. A thin layer of Skinfuse Lift HG was applied prior to treatment area to protect against abrasion and friction during the procedure. The aestheticians were instructed to treat at depths of up to 2.5 mm. Following treatment, Skinfuse Lift HG was applied to prevent the skin from drying out post procedure.

| | SkinPen Precision System | |
|---------------------------|--------------------------|------|
| N | 32 | |
| Age (years) | | |
| Mean (standard deviation) | 56.3 (5.0) | |
| Minimum, Median, Maximum | 44, 56.5, 65 | |
| | N | (%) |
| Sex | | |
| Male | 2 | 6.3 |
| Female | 30 | 93.8 |
| Ethnicity | | |
| Hispanic or Latino | 4 | 12.5 |
| Not Hispanic or Latino | 28 | 87.5 |
| Race | | |
| Other | 4 | 12.5 |
| White or Caucasian | 28 | 87.5 |
| Fitzpatrick Skin Type | | |
| II | 24 | 75.0 |
| III | 4 | 12.5 |
| IV | 4 | 12.5 |

| Table 1: Summary of Demographic Information Per Protocol |
|----------------------------------------------------------|
|----------------------------------------------------------|

At each clinical visit. digital images were taken of each subject's wrinkles on the neck. These images were graded by two separate independent blinded Board Certified Physicians after completion of the study using the following assessment tools and timepoints [Tables 2-5]. The results of the study are provided in Tables 6-10.

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| Table 2: Study Endpoints | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary<br>Effectiveness<br>Endpoints | G. Lemperle Wrinkle Scale graded by two blinded graders using photographs<br>taken at day 1 and 3-months post-treatment |
| Secondary<br>Effectiveness<br>Endpoint | Clinician's Global Aesthetic Improvement Assessment graded by two blinded<br>graders using photographs taken at day 1 and 3-months post-treatment |
| | Subject Global Aesthetic Improvement Scale completed by subjects at 1-<br>month post-treatment, and 3-months post-treatment |
| | Patient Satisfaction Questionnaire completed by subjects at 1-month post-<br>treatment and 3-months post-treatment |
| Safety<br>Endpoint | Subject safety diaries provided to the subject at each treatment visit (day 1,30,<br>60 and 90) and completed for 30 days to record treatment responses |
| | Adverse event monitoring at each visit; day 1, day 30, day 60, day 90, 1-month<br>post-treatment and 3 months post-treatment |

Subjects had wrinkling assessed on the neck using the G. Lemperle Wrinkle Assessment Scale.

| Class | Description |
|-------|-----------------------------------|
| 0 | No wrinkles |
| 1 | Just perceptible wrinkle |
| 2 | Shallow wrinkles |
| 3 | Moderately deep wrinkle |
| 4 | Deep wrinkle, well-defined edges |
| 5 | Very deep wrinkle, redundant fold |

Table 3: Assessment of Wrinkling – G. Lemperle Wrinkle Scale

At 1 month post-treatment and 3 months post-treatment, subjects also participated in the following procedures:

- Clinician's Global Aesthetic Improvement Scale ●
#### Table 4: Clinician's Global Aesthetic Improvement Scale

| Rating | Description |
|--------|-----------------------------------------------------------------------------------------------------------------------------|
| 1 | Very Much Improved: Optimal cosmetic result in this subject. |
| 2 | Much Improved: Marked improvement in appearance from the initial condition, but not<br>completely optimal for this subject. |
| 3 | Improved: Obvious improvement in appearance from initial condition, but are-<br>treatment is indicated. |
| 4 | No Change: The appearance is essentially the same as the original condition. |
| 5 | Worse: The appearance is worse than the original condition. |

- Subject's Global Aesthetic Improvement Scale ●
#### Table 5: Subject Global Aesthetic Improvement Scale

| Rating | Description |
|--------|------------------------------------------------------------------------------------------------------------|
| 1 | Very Much Improved: Optimal cosmetic result. |
| 2 | Much Improved: Marked improvement in appearance from the initial condition, but not<br>completely optimal. |
| 3 | Improved: Obvious improvement in appearance from initial condition. |
| 4 | No Change: The appearance is essentially the same as the original condition. |
| 5 | Worse: The appearance is worse than the original condition. |

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- Patient Satisfaction Questionnaire ●
Subjects completed a Sponsor-provided questionnaire regarding improvement in wrinkles, satisfaction with the treatment and willingness to recommend the treatment to friends and family members.

#### Results:

#### Safety:

#### a. What side effects were seen in the clinical study?

Common Treatment Responses on the face and neck:

Common Treatment responses of dryness, redness, burning sensation and itchiness which lasted the duration of 1-3 days. Reactions of tenderness and peeling/flaking occurred for the duration of 1-7 days.

The following common treatment responses were reported in the subject safety diaries which were sent home with the subject:

- Dryness in 7/32 (22%) subjects lasting from 1-3 days ●
- These responses were reported by 6 subjects with FST II, 1 subject with O FST IV
- Redness in 2/32 (6%) subjects lasting from 1-3 days ●
- These responses were reported by 2 subjects, 1 subject with FST II, 1 O subject with FST IV
- Itching in 1/32 (3%) subjects with FST II, lasting from 1-2 days
- Peeling was reported in 8/32 (22%) of subjects lasting 1-3 days
- These responses were reported by 8 subjects. 5 subjects with FST II, 1 O subject with FST III, 2 subjects with FST IV
- Tenderness that lasted 1-4 days in 1/32 (3%) of Subjects , with FST II ●
- Burning in 2/32 (6%) of subjects lasting 1-3 days ●
- o These responses were reported by 2 subjects with FST IV

#### b. What adverse events were seen in the clinical study?

At the 3-month post-treatment visit, no adverse events were seen.

No adverse events related to the SkinPen Precision treatment were observed on the face and neck during the study.

## c. What are other possible adverse events?

Although not seen in the clinical study, patients may experience red and flushed skin, skin tightness and mild sensitivity to touch (such as itching, burning, stinging, tingling), scaling/dryness, redness, edema and tenderness/discomfort.

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## Benefits:

## What will a SkinPen Precision Treatment accomplish, and what did the clinical study show?

The study doctors reported using the G. Lemperle Wrinkle Scale:

Results of the photo grading indicated a significant improvement in wrinkles on the neck area assessment at 3 months post- treatment.

Table 6: Results of Photo Grading of G. Lemperle Wrinkle Scale for SkinPen Precision System

| Detail | Time Point | N | Mean | Standard<br>Deviation | Min | Median | Max |
|--------|--------------------------|----|------|-----------------------|------|--------|------|
| Neck | Day 1 | 32 | 3.31 | 0.74 | 2.00 | 3.25 | 5.00 |
| | 3 Mo. Post-<br>Treatment | 32 | 2.45 | 0.93 | 1.00 | 2.00 | 4.50 |

Table 7: Change from Baseline for Photo Grading of G. Lemperle Wrinkle Scale for SkinPen Precision System

| Detail | Time Point | N | Subjects graded as having ≥1 grade improvement |
|--------|----------------------|----|------------------------------------------------|
| Neck | 3 Mo. Post-Treatment | 32 | 16 (50%) |

## Clinician's Global Aesthetic Improvement Assessment:

Treatment with SkinPen Precision produced an improvement in CGAIS scores at 3 months post-treatment. At three-months post-treatment evaluation. 31.5% of subjects received a '3: improved' grading and 57% received a grading of '4: no change' relative to pre-treatment. Four subjects (11.5%) received a grading of '2: much improved'.

## Subjects reported using the Subject Global Aesthetic Improvement Scale:

Treatment with SkinPen Precision produced an improvement in Subject GAIS scores at 3-months post-treatment. At 3-months post-treatment, 22 (68.8%) subjects reported some percentage of improvement in the appearance of their wrinkles, with 10 (31.3%) subjects reporting no change.

# Subjects reported using the Patient Satisfaction Questionnaire:

The results of the patient satisfaction questionnaire for all subjects indicated that a greater number of subjects selected favorable responses regarding treatments at 1 month and 3 months post-treatment for the following inquiries:

- . Question 1: Do you notice any improvement in how your fine lines and wrinkles look in the treated area?

| Time Point | Yes [N (%)] | No [N, (%)] |
|-------------------------|-------------|-------------|
| 1-Month Post-Treatment | 30 (93.8) | 2 (6.3) |
| 3-Months Post-Treatment | 23 (71.9) | 9(28.1) |

Table 8: Results of Patient Satisfaction Questionnaire - Question 1

- Question 2: How would you characterize your satisfaction with the treatment?

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| Time Point | N | Favorable (+)<br>N (%) | Unfavorable (-)<br>N (%) | Neutral<br>N (%) |
|-------------------------|----|------------------------|--------------------------|------------------|
| 1 Month Post-Treatment | 32 | 28 (87.5) | 3 (9.4) | 1 (3.1) |
| 3 Months Post-Treatment | 32 | 24 (75.0) | 6 (18.8) | 2 (6.3) |

Table 9: Results of Patient Satisfaction Ouestionnaire – Question 2

#### Question 3: Would you recommend this treatment to your friends and family ● members?

| Table 10: Results of Patient Satisfaction Questionnaire - Question 3 | | |
|----------------------------------------------------------------------|-------------|-------------|
| | | |
| Time Point | Yes [N (%)] | No [N, (%)] |
| 1-Month Post-Treatment | 25 (80.6) | 6 (19.4) |
| 3-Months Post-Treatment | 21 (65.6) | 11 (34.4) |

Subjects were informed of the following potential common treatment responses in the informed consent process: skin will be red and flushed similar to a moderate sunburn, skin tightness and mild sensitivity to the touch, redness, burning, tingling, stinging, itching, and/or scaling/dryness, edema (swelling), tenderness/ discomfort, a possibility of developing an infection (an increase in redness, warmth, itching, or pus formation). The diaries included space for daily recording of observations for the 30 days in between treatment visits. Adverse events were assessed by the investigator at each subsequent visit.

## 13. Statement of Substantial Equivalence:

Crown Aesthetics has demonstrated that the SkinPen® Precision System has the same device classification, same intended use and basic technological characteristics as the predicate device. The new indication for use is supported by clinical evidence.