Who is the manufacturer of PiXel8-RF?

Rohrer Aesthetics filed the 510(k) submission for PiXel8-RF (K233147).

What is the FDA product code for PiXel8-RF?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for PiXel8-RF?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like PiXel8-RF?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PiXel8-RF

K233147 · Rohrer Aesthetics · GEI · Oct 25, 2023 · General, Plastic Surgery

Device Facts

Record ID	K233147
Device Name	PiXel8-RF
Applicant	Rohrer Aesthetics
Product Code	GEI · General, Plastic Surgery
Decision Date	Oct 25, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The PiXel8-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.

Device Story

PiXel8-RF is a bipolar radiofrequency (RF) electrosurgical system used in clinical settings by healthcare providers. The device consists of a main console, footswitch, LCD touch screen, and a handpiece with disposable micro-needle electrode tips. The operator places the micro-needle tip in light contact with the target tissue at a right angle. Upon activation, the device delivers high-frequency RF energy through the needles into the tissue. This energy generates an electrothermal reaction, causing tissue coagulation and hemostasis. The system is used for dermatologic and general surgical procedures. The output allows the clinician to perform controlled thermal coagulation, benefiting the patient by facilitating surgical hemostasis.

Clinical Evidence

No clinical study was conducted. Evidence consists of bench testing and in-vivo animal tissue testing. Bench testing included IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), and IEC 60601-2-2 (high-frequency surgical equipment). In-vivo testing on liver, kidney, and muscle tissue confirmed measurable thermal damage with no instances of unexpected injury.

Technological Characteristics

Bipolar RF electrosurgical system; 4 MHz frequency; max power 25W at 500 ohm; RF duration 50-950ms; disposable micro-needle electrode tips (25, 49, 64 pins); 8-inch LCD touch screen interface; air cooling; electrical rating 110-230VAC. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.

Indications for Use

Indicated for patients undergoing dermatologic and general surgical procedures requiring electrocoagulation and hemostasis.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

Pinxel RF System (K180654)

Related Devices

K180654 — PINXEL-RF system · Rohrer Aesthetics, LLC · Jul 13, 2018
K170325 — SECRET RF · Ilooda Co,., Ltd. · Jun 13, 2017
K231749 — Radio Frequency System · Shenzhenshi Sincoheren S&T Development Co., Ltd. · Oct 19, 2023
K243713 — Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) · Agnes Medical Co., Ltd. · Aug 19, 2025
K213612 — SYLFIRM X · VIOL Co., Ltd. · Jun 23, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ 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 seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". October 25, 2023 Rohrer Aesthetics Mark Rohrer President 105 Citation Court Homewood, Alabama 35209 Re: K233147 Trade/Device Name: PiXel8-RF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, OUH Dated: September 27, 2023 Received: September 27, 2023 Dear Mark Rohrer: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.10.25 08:03:32 -04'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices {2}------------------------------------------------ Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233147 Device Name PiXel8-RF Indications for Use (Describe) The PiXel8-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis. Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |-----------------------------------------------------------------------------------------------------|-----------------------------------------------| |-----------------------------------------------------------------------------------------------------|-----------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ This 510(K) Summary of safety and effectiveness for the PIXEL8-RF System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary. | Applicant: | Rohrer Aesthetics | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Rohrer Aesthetics 105 Citation Court Birmingham, AL 35209 | | Contact Person: | Mr. Mark Rohrer | | Telephone: | 205-356-1172 – phone mrohrer@rohreraesthetics.com | | Preparation Date: | September 18, 2023 | | Type of Submission: | Special 510K | | Device Trade Name: | Pixel8-RF System | | Common Name: | Micro-Needle Fractional RF | | Regulation Name: | Electrosurgical Cutting and Coagulation Device 79-GEI | | Regulation Number: | 21 CFR 878.4400 | | Product Code: | GEI, OUH | | LegallyMarketed Predicate Device(s): | Pixel8-RF (K180654) | | Description of the PIXEL8-RF System: | The Pixel8-RF System includes the system main body, a bipolar handpiece with disposable micro-needle type electrodes, a footswitch and an LCD touch screen control panel. | | | The RF Energy is delivered to a target tissue using a handpiece and disposable tip (micro needle electrode tip), the being placed in light contact with the tissue and the handpiece being held at right angles to the target tissue. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The Pixel8-RF System | {5}------------------------------------------------ ### 510(K) Summary PiXel8-RF System creates heat within the target tissue using micro-needles inserted from the tip. - Intended use of the The PIXEL8-RF system is intended for use in dermatologic and PIXEL8-RF System general surgical procedures for electrocoagulation and hemostatis. - Performance Data: The following performance data was provided in support of the substantial equivalence determination: IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility IEC 60601-2-2 Medical electrical equipment part 2: particular requirements for the basic safety and essential performance of high frequency surgical equipment In-Vivo testing was conducted on 3 types of tissue: Liver, Kidney and Muscle with results analyzed in a pathology lab. Results showed measurable thermal damage and no instances of unexpected injury. Results of Clinical Study: No clinical study was conducted to support this 510K submission. Technical Specifications Comparison: {6}------------------------------------------------ ## 510(K) Summary PiXel8-RF System | | PiXel8 RF System (Subject Device) | Pinxel RF System (Predicate Device) K180654 | |----------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Model | Pixel8 RF System | Pinxel RF System | | Manufacturer | Rohrer Aesthetics | Rohrer Aesthetics | | System Type | BiPolar RF | BiPolar RF | | Output Energy Type | High Frequency | High Frequency | | Frequency | 4 MHz | 2 MHz | | Max Power | Max 25 W@ 500 ohm | Max 25 W @ 500 ohm | | Total RF Treatment Level | Up to 20 (Max power 25 W) | Up to 20 (Max power 25W) | | RF Duration | 50 ms – 950ms | 50ms - 950ms | | Tips | MicroNeedle Electrodes 25, 49 and 64 pins | MicroNeedle Electrodes 25 and 64 pins | | User interface | 8" Touch LCD Display | Color touch LCD Display | | System cooling | Air cooling | Air cooling | | Dimensions (including Handpiece cable hanger | 24 inches x 17 inches x 63 inches | 24 inches x 17 inches x 63 inches) | | Weight | 8 lbs (without cart) | 8 lbs (without cart) | | Electrical rating | Single phase 110 - 230VAC, 60- 60Hz Power consumption: 500VA (Fuse: 250V/6.3A) | Single phase 110 - 230VAC, 60- 60Hz Power consumption: 500VA (Fuse: 250V/6.3A) | # Conclusion: The difference in the frequency does not raise new or different questions of safety or effectiveness. The performance data demonstrate that the subject device is as safe and effective as its predicate device for the intended use. Therefore, the PiXel8-RF system is substantially equivalent to its predicate device.