Who is the manufacturer of PINXEL-RF system?

Rohrer Aesthetics, LLC filed the 510(k) submission for PINXEL-RF system (K180654).

What is the FDA product code for PINXEL-RF system?

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 PINXEL-RF system?

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

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

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.

PINXEL-RF system

K180654 · Rohrer Aesthetics, LLC · GEI · Jul 13, 2018 · General, Plastic Surgery

Device Facts

Record ID	K180654
Device Name	PINXEL-RF system
Applicant	Rohrer Aesthetics, LLC
Product Code	GEI · General, Plastic Surgery
Decision Date	Jul 13, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Device Story

PINXEL-RF system delivers bipolar radiofrequency (RF) energy to target tissue via disposable micro-needle electrode tips. System comprises main body, bipolar handpiece, footswitch, and LCD touch screen control panel. Physician operates device by placing tip in light contact with tissue at right angles. RF energy passes through tissue, generating electro-thermal reaction for coagulation and hemostasis. Micro-needles facilitate energy delivery within target tissue. Used in clinical settings for dermatologic and general surgical procedures. Output allows physician to control coagulation effects, potentially benefiting patients through precise tissue treatment.

Clinical Evidence

Bench testing only. Included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and high-frequency surgical equipment safety (IEC 60601-2-2). Sterilization validation performed per ISO 11737-2. In-vivo testing conducted on liver, kidney, and muscle tissue; pathology analysis showed no unexpected injury.

Technological Characteristics

Bipolar RF electrosurgical device. Frequency: 2 MHz. Max power: 25W @ 500 ohm. RF duration: 50-950ms. Disposable micro-needle electrode tips (25 and 64 pins). User interface: 8-inch touch LCD. Electrical: 110-230VAC, 500VA. Sterilization: Microbiological methods per ISO 11737-2.

Indications for Use

Indicated for dermatologic and general surgical procedures requiring electrocoagulation and hemostasis. Prescription use only.

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

Secret RF (K170325)

Related Devices

K231749 — Radio Frequency System · Shenzhenshi Sincoheren S&T Development Co., Ltd. · Oct 19, 2023
K233147 — PiXel8-RF · Rohrer Aesthetics · Oct 25, 2023
K180945 — LUTRONIC GENIUS Radiofrequency System · Lutronic Corporation · Dec 10, 2018
K183284 — INTRAcel RF Microneedle System · Jeisys Medical, Inc. · Jan 15, 2020
K170325 — SECRET RF · Ilooda Co,., Ltd. · Jun 13, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). To 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. July 13, 2018 Rohrer Aesthetics, LLC Mark Rohrer President 105 Citation Court Birmingham, Alabama 35209 Re: K180654 Trade/Device Name: PINXEL-RF system Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, OUH Dated: June 13, 2018 Received: June 14, 2018 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 (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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Binita S. Ashar -S Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) 510(K) Pending Device Name PINXEL-RF System Indications for Use (Describe) The PINXEL-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. 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." {3}------------------------------------------------ #### K180654 Attachment 5 510(K) Summary PINXEL-RF System This 510(K) Summary of safety and effectiveness for the PINXEL-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, LLC | |------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Rohrer Aesthetics, LLC 105 Citation Court Birmingham, AL 35209 | | Contact Person: | Mr. Mark Rohrer | | Telephone: | 205-356-1172 — phone mrohrer@rohreraesthetics.com | | Preparation Date: | February 17, 2018 | | Device Trade Name: | PINXEL-RF System | | Common Name: | Micro-Needle Fractional RF | | Regulation Name: | Electrosurgical Cutting and Coagulation Device & Acessories | | Regulation Number: | 21 CFR 878.4400 (Product Code: GEI, OUH) | | Legally Marketed Predicate Device: 510(K) number: | Secret RF Manufactured by ILOODA CO LTD. K170325 | | Regulatory Class: | Class II Prescription Use | | Description of the PINXEL-RF System: | The PINXEL-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 tip being placed in light contact with the tissue and the handpiece being held at right angles to the targettissue. As the RF energy passes through the tissue, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the micro needle tip, the PinXel system creates heat within the target tissue via micro- needles inserted from the tip. | | Intended use of the PINXEL-RF System | The PINXEL-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatic. | {4}------------------------------------------------ #### K180654 #### Attachment 5 510(K) Summary PINXEL-RF System 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 60501-1-2 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 ાડળ 11737-2 Sterilization of medical devices --Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process In-Vivo testing was conducted on 3 types of tissue: Liver Kidney and Muscle with results analyzed in a pathology lab. Results showed no instances of unexpected injury. Technical Specifications Comparison: {5}------------------------------------------------ #### K180654 Attachment 5 510(K) Summary PINXEL-RF System | | Proposed Device | Predicate Device | |----------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Model: | PinXel RF Device | Secret | | Manufacturer: | Rohrer Aesthetics | ILOODA Co Ltd. | | System Type | BiPolar RF | BiPolar RF | | Output Energy type: | High Frequency | High Frequency | | Frequency | 2 MHz | 2 MHz | | Max.Power | Max 25 W @ 500 ohm | Max 25W @ 500 ohm | | Total Power delivered per treatment | 25W | 25W | | Power per pin | 25W | 25W | | RF Duration | 50ms-950ms | 50ms-950ms | | Tips | MicroNeedle Electrodes 25 and 64 pins | MicroNeedle Electrodes 25 and 64 pins | | User interface | 8" Touch LCD Display | Color touch LCD Display | | Dimensions (including Handpiece cable hanger | 24 inches x 17 inches x 63 inches | 7.5 inches x 18.5inches x 43.5 inches (180(W) x 460(D) x 1100 (H)) | | Weight | 8 lbs ( without cart) | 45 kg. (99 pounds) | | 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 treatment tip design does not raise new or different questions of safety or effectiveness. Furthermore, performance data demonstrate that the subject device is as safe and effective as its predicate device for requested intended use. Therefore, PINXEL-RF System is substantially equivalent to its predicate device.