(235 days)
No
The description focuses on the mechanical action of microneedling and does not mention any AI/ML components or functions. The image analysis described is performed by human physicians.
Yes.
The device is intended to improve the appearance of wrinkles and acne scars, which are physical conditions, indicating a therapeutic purpose.
No
The device is described as a microneedling device intended as a treatment to improve the appearance of wrinkles and acne scars, not to diagnose a condition.
No
The device description clearly outlines hardware components including a microneedling pen handpiece, sterile needle cartridge, charging base, and BioSheath.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "improve the appearance of wrinkles of the neck" and "improve the appearance of facial acne scars." This describes a therapeutic or aesthetic treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "microneedling pen handpiece" and "sterile needle cartridge." This is a physical device used to perform a procedure on the skin.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SkinPen® Precision system does not fit this description.
N/A
Intended Use / Indications for 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.
Product codes
QAI
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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neck, Face
Indicated Patient Age Range
Adults aged 22 years and older (for facial acne scars);
44 years and older (for neck wrinkles in clinical study)
Intended User / Care Setting
Healthcare professionals trained in use of the device; Clinical environment.
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
A clinical study was 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).
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: G. Lemperle Wrinkle Scale and Clinician's Global Aesthetic Improvement Assessment.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Study
Sample Size: 35 subjects initially enrolled, 32 subjects completed per protocol for performance analysis.
Key Results:
Safety:
Common treatment responses on the face and neck experienced by subjects included dryness, redness, burning sensation, itchiness, tenderness, and peeling/flaking. These generally lasted from 1 to 7 days.
No adverse events related to the SkinPen Precision treatment were observed on the face and neck during the study at the 3-month post-treatment visit.
Effectiveness (Wrinkles on the Neck):
-
G. Lemperle Wrinkle Scale (Photo Grading):
- Results indicated a significant improvement in wrinkles on the neck area assessment at 3 months post-treatment.
- Mean G. Lemperle Wrinkle Scale score decreased from 3.31 (Day 1) to 2.45 (3 Months Post-Treatment).
- 16 out of 32 subjects (50%) were graded as having ≥1 grade improvement at 3 months post-treatment.
-
Clinician's Global Aesthetic Improvement Assessment (CGAIS):
- At 3 months post-treatment evaluation, 31.5% of subjects received a '3: improved' grading.
- 57% received a grading of '4: no change' relative to pre-treatment. (Note: The provided text states 31.5% and 57%, which sum to 88.5%; the remaining 11.5% received '2: much improved').
- Four subjects (11.5%) received a grading of '2: much improved'.
-
Subject Global Aesthetic Improvement Scale (SGAIS):
- At 3 months post-treatment, 22 (68.8%) subjects reported some percentage of improvement in the appearance of their wrinkles.
- 10 (31.3%) subjects reported no change.
-
Patient Satisfaction Questionnaire:
- Question 1 (Notice any improvement in fine lines and wrinkles):
- 1-Month Post-Treatment: 30 (93.8%) said Yes.
- 3-Months Post-Treatment: 23 (71.9%) said Yes.
- Question 2 (Satisfaction with the treatment):
- 1-Month Post-Treatment: 28 (87.5%) favorable.
- 3-Months Post-Treatment: 24 (75.0%) favorable.
- Question 3 (Recommend to friends and family):
- 1-Month Post-Treatment: 25 (80.6%) said Yes.
- 3-Months Post-Treatment: 21 (65.6%) said Yes.
- Question 1 (Notice any improvement in fine lines and wrinkles):
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Improvement in G. Lemperle Wrinkle Scale score, percentage of subjects demonstrating improvement based on clinician and subject global aesthetic improvement scales, and patient satisfaction percentages.
Predicate Device(s)
K180778 Exceed Microneedling Device
Reference Device(s)
DEN160029 SkinPen® Precision System
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 for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
-
- Submitter and Owner:
Crown Aesthetics 5005 Lyndon B. Johnson Freeway Suite 370 Dallas, Texas 75244, USA
- Submitter and Owner:
-
- Official Correspondent:
Marie Fogartie, Director of Regulatory Affairs Phone: 423-630-2296 Email: mfogartie@crownlaboratories.com
- Official Correspondent:
-
- Submission Type: Traditional 510(k)
-
- Proprietary Name: SkinPen® Precision System
-
- Device Classification Information: Classification Name: Microneedling Device for Aesthetic Use Regulation Number: 878.4430 Product Code: QAI Device Class: 2
-
- Predicate Device: K180778 Exceed Microneedling Device Reference Device: DEN 160029 SkinPen® Precision System
-
- 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.
-
- 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.
4
9. Indications for Use Comparison:
| Subject Device | Predicate Device | |
|---|---|---|
| K202243 | K180778 | |
| Indication for | ||
| 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. | The Exceed is a microneedling | |
| device and accessories is intended | ||
| for the treatment of wrinkles in | ||
| Fitzpatrick skintypes I, II and/or | ||
| III in the following facial areas: | ||
| glabellar frown lines, periorbital | ||
| lines and cheek folds in adults | ||
| aged 22 years or older |
10. Technological characteristics comparison:
| Characteristic | Subject Device
K202243 | Predicate Device
K180778 |
|-----------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------|
| Trade Name | SkinPen® Precision System | Exceed Microneedling device |
| Classification
Name | Microneedling device for aesthetic
use | Microneedling device for aesthetic
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
use of the device | Healthcare professionals trained in
use of the device |
| Environment | Clinical | Clinical |
| Treatment Area | Face and Neck | Face |
| Shape of needle
cartridge | Round | Squared |
| Needles | 14 total solid medical grade
stainless steel | 6 needles, squared arrangement
medical grade stainless steel |
| Needle Protrusion
settings | 0—2.5 mm | 0 - 1.9 mm |
| Max. Needle
Length used in the
clinical study | 2.5 mm | 1.5 mm |
| Frequency | 6300 RPM to 7700 RPM (105-
128.3 Hz) | 6300 RPM to 7700 RPM (100-150
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.
5
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.
6
| Table 2: Study Endpoints | |
|---|---|
| Primary | |
| Effectiveness | |
| Endpoints | G. Lemperle Wrinkle Scale graded by two blinded graders using photographs |
| taken at day 1 and 3-months post-treatment | |
| Secondary | |
| Effectiveness | |
| Endpoint | Clinician's Global Aesthetic Improvement Assessment graded by two blinded |
| graders using photographs taken at day 1 and 3-months post-treatment | |
| Subject Global Aesthetic Improvement Scale completed by subjects at 1- | |
| month post-treatment, and 3-months post-treatment | |
| Patient Satisfaction Questionnaire completed by subjects at 1-month post- | |
| treatment and 3-months post-treatment | |
| Safety | |
| Endpoint | Subject safety diaries provided to the subject at each treatment visit (day 1,30, |
| 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 | |
| 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 |
| completely optimal for this subject. | |
| 3 | Improved: Obvious improvement in appearance from initial condition, but are- |
| 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 |
| 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. |
7
- 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.
8
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
Deviation | Min | Median | Max |
|--------|--------------------------|----|------|-----------------------|------|--------|------|
| Neck | Day 1 | 32 | 3.31 | 0.74 | 2.00 | 3.25 | 5.00 |
| | 3 Mo. Post-
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?
9
| Time Point | N | Favorable (+)
N (%) | Unfavorable (-)
N (%) | Neutral
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.