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
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 423-630-2296 Email: mfogartie@crownlaboratories.com
- 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.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
