Who is the manufacturer of Profound Matrix?

Candela Corporation filed the 510(k) submission for Profound Matrix (K211217).

What is the FDA product code for Profound Matrix?

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 Profound Matrix?

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

Who can help prepare an FDA 510(k) submission like Profound Matrix?

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.

Profound Matrix

K211217 · Candela Corporation · GEI · Dec 16, 2021 · General, Plastic Surgery

Device Facts

Record ID	K211217
Device Name	Profound Matrix
Applicant	Candela Corporation
Product Code	GEI · General, Plastic Surgery
Decision Date	Dec 16, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The PROFOUND MATRIX SYSTEM is intended for dermatological procedures, as follows: The MATRIX PRO applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis. The SUBLATIVE RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62mJ/pin, the Sublative RF applicator is limited to Fitzpatrick Skin Types I-IV. The SUBLIME applicator is indicated for non-invasive wrinkle treatment. At higher energy levels, greater than 100 J/ cm3, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV.

Device Story

Profound Matrix System is a multi-applicator electrosurgical device for dermatological procedures. It utilizes three applicators: Matrix Pro (bipolar RF microneedling for electrocoagulation/hemostasis), Sublative RF (bipolar RF for skin ablation/resurfacing/wrinkles), and Sublime (combined IR light and bipolar RF for non-invasive wrinkle treatment via bulk dermal heating). Operated by physicians in clinical settings, the system uses a touchscreen interface to adjust parameters like needle depth, RF energy, and power density. The Matrix Pro applicator features impedance-based energy control to deliver precise thermal doses. The device transforms electrical energy into thermal energy at the skin surface or within the dermis to stimulate tissue healing and collagen remodeling. Clinical benefits include improved skin appearance and wrinkle reduction. The system is intended for professional use.

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1, 60601-1-2, 60601-2-2), biocompatibility (ISO 10993), software validation, and ex-vivo thermal damage evaluation on excised abdominal skin. Ex-vivo testing confirmed that the Matrix Pro produces thermal effects (collagen denaturation, fat cell membrane disruption) consistent with the predicate Infini device.

Technological Characteristics

System console with touchscreen interface. Applicators: Matrix Pro (49 microneedles, 1 MHz bipolar RF), Sublative RF (multi-electrode pin array, 1 MHz bipolar RF), Sublime (IR 700-2000 nm + 1 MHz bipolar RF). Materials: Biocompatible patient-contacting components per ISO 10993. Energy: Bipolar RF and IR. Connectivity: Standalone console. Sterilization: Sterile microneedle tips. Software: Controlled by impedance sampling for energy delivery.

Indications for Use

Indicated for dermatological procedures including electrocoagulation, hemostasis, skin ablation, resurfacing, and treatment of facial wrinkles. Sublative RF and Sublime applicators at higher energy levels are restricted to Fitzpatrick Skin Types I-IV.

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

Lutronic Infini (K121481)

Reference Devices

Syneron Medical Ltd eTwo Skin Treatment System (K141507, K110672)
Syneron Candela Corporation Profound System (K161043)

Related Devices

K240070 — Profound Matrix · Candela Corporation · Jul 1, 2024
K161043 — Profound System · Syneron Candela Corporation · Sep 12, 2016
K141507 — TWO SKIN TREATMENT SYSTEM · Syneron Medical, Ltd. · Dec 8, 2014
K210492 — InMode RF Pro System · Inmode MD , Ltd. · Jul 12, 2021
K173503 — Pollogen Legend System · Pollogen, Ltd. · Jun 11, 2018

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 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. December 16, 2021 Candela Corporation Rina Ordonez 251 Locke Dr Marlborough, Massachusetts 01752 Re: K211217 Trade/Device Name: Profound Matrix Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 19, 2021 Received: November 22, 2021 Dear Rina Ordonez: 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, {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K211217 Device Name Profound Matrix Indications for Use (Describe) The PROFOUND MATRIX SYSTEM is intended for dermatological procedures, as follows: The MATRIX PRO applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis. The SUBLATIVE RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62mJ/pin, the Sublative RF applicator is limited to Fitzpatrick Skin Types I-IV. The SUBLIME applicator is indicated for non-invasive wrinkle treatment. At higher energy levels, greater than 100 J/ cm3, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div> <input checked="true" type="checkbox"/> Executive Use (Part 91, 125) Private Pleasure </div> | <div> <input type="checkbox"/> For-Hire, Commercial (Part 135, 121) </div> | |-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| X 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}------------------------------------------------ # 510(k) Summary — K211217 Profound Matrix System This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92 #### 1. DATE PREPARED April 21, 2021 #### 2. SUBMITTER Candela Corporation 251 Locke Drive Marlborough MA 01752 USA ### 3. OFFICIAL CORRESPONDENT Rina Ordonez Senior Regulatory Affairs Specialist Candela Corporation 251 Locke Dr. Marlborough, MA 01752 Office: 508-834-6072 Email: rinao@candelamedical.com #### 4. DEVICE INFORMATION | Proprietary Name: | Profound Matrix™ | |------------------------|------------------------------------------------------------------------------------------| | Common/Usual Name: | Electrosurgical coagulation device and accessory | | Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR Part 878.4400) | | Product Code: | GEI | | Device Classification: | Class II | #### 5. PREDICATE DEVICE Primary Predicate: Lutronic Infini (K121481) Reference Devices: Syneron Medical Ltd eTwo Skin Treatment System (K141507, K110672), Syneron Candela Corporation Profound System (K161043) ### 6. INTENDED USE/INDICATION FOR USE The PROFOUND MATRIX SYSTEM is intended for dermatological procedures, as follows: {4}------------------------------------------------ ## 510(k) Summary — K211217 The MATRIX PRO applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis. The SUBLATIVE RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62 mJ/pin, the Sublative RF applicator is limited toFitzpatrick Skin Types I-IV. The SUBLIME applicator is indicated for non-invasive wrinkles treatment. At higher energy levels greater than 100 J/cm³, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV. ### DEVICE DESCRIPTION 7. The Profound Matrix System combines three existing technologies and applications for dermatological procedures. Each respective technology is used in one of the three applicators designed for the Profound Matrix System. These three applicators are named: Matrix Pro, Sublative RF and Sublime. The Matrix Pro applicator is designed to deliver bipolar, non-ablative radiofrequency energy through a 7x7 matrix/grid of sterile microneedles to the skin in a fractional manner. The microneedles can be set up to pulse a maximum of three depths during each insertion of the matrix/grid of microneedles with a maximum depth of up to 3.5mm. The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface viaan array of multi-electrode pin tips. The applicator delivers bipolar RF energy to the skin, which results in heating of demarcated spots to temperatures that ablate and resurface at contact points of the multi-electrode pins. The Sublime applicator uses a combination of an infrared (IR) light source and bipolar radiofrequency (RF) to bulk heat the dermis and affect dermal collagen in order to treat wrinkles. The bulk heating of the dermal layers refers to the gradual and gentle accumulation of heat with each additional pass performed. #### 8. TECHNOLOGICAL CHARACTERISTICS The technological characteristics comparison between the Profound Matrix System and its predicates is done per applicator and system console, as each applicator incorporates different technology, and the console enables each technology. The following table (Table 8-1) compares the key technological characteristics and features of the Profound Matrix System to the predicate device. The tables that follow compare the key technical characteristics and features of the different applicators with predicate and reference devices (Tables 8-2, 8-3, and 8-4). {5}------------------------------------------------ | Predicate and Reference Devices | | | Reference Device | Reference Device | | Reference Devices | | | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------| | Specifications | Subject Device | Predicate Device | | | Specifications | Profound Matrix- Matrix Pro (Subject Device) | Infini Infini Handpiece K121481 (Predicate Device) | Profound Profound Dermal K161043 (Reference Device #2) | | | | Profound Matrix | Infini Radiofrequency System (K121481) | eTwo (K141507) | Applicator Type | Short Pulse Microneedling | Short Pulse Microneedling | Long Pulse Microneedling | | Indications for Use | The PROFOUND MATRIX SYSTEM is Intended for dermatological procedures, as follows: The MATRIX PRO applicator is intended for use in dermatologic, procedures for electrocoagulation and hemostasis. The SUBLATIVE RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62 mJ/pin, the Sublative RF applicator is limited to Fitzpatrick skin types I-IV. The SUBLIME applicator is indicated for non- invasive wrinkles treatment At | The INFINI Radiofrequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. | The eTwo Skin Treatment System is intended for dermatological procedures. The Sublative RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62 mJ/pin, the Sublative RF applicator is limited to skin types I-IV. The Sublime applicator is indicated for non-invasive wrinkles treatment. At higher energy levels greater than 100 J/cm3, the Sublime applicator is | The Profound System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Specifically, the 25º Dermal handpiece and cartridge are used for percutaneous treatment of facial wrinkles, and the 75º SubQ handpiece and cartridge are used to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III as supported by long- term clinical data (6 months). | Applicator Dimensions | 14.4 x 14.3 cm / 5.7 x 5.6" [W x H] | Unknown | 19.4 x 13.9 cm / 7.6 x 5.5" | | Specifications | Subject Device | Predicate Device | Reference Device | Reference Device | Energy Source | Matrix Pro: Radio Frequency | Infini handpiece: Radio Frequency | Profound Dermal Cartridge: Radio Frequency | | | Profound Matrix | Infini Radiofrequency System (K121481) | eTwo (K141507) | Profound System (K161043) | RF Mode of operation | Bipolar | Bipolar | Bipolar | | | higher energy levels greater than 100 J/cm3, the Sublime applicator is limited to Fitzpatrick skin types I-IV | | limited to skin types I-IV. | | RF Frequency | 1 MHz | 1 MHz | 460±5 kHz | | Device Dimensions | 39.4 x 57.4 x 135.6 cm | 36.2 x 40.9 x 171.3 cm | 30 x 23 x 53 cm | 46.5x 44.5 x 125 cm | Disposable Tip Area Coverage & Injection Pattern | 1 cm² Square | 49 needle Tip 1 cm² 16 needle Tip 0.36 cm² Square | 1.4 cm x 0.16 cm Pseudo- Linear | | Weight (Pounds, Kg) | 50, 22.5 | 61.7, 28 | 18.7, 8.5 | 55, 23 | RF Pulse duration | Up to 280 ms | 10 to 1000 ms | 3-5 seconds | | Power Supply | Yes | Yes | Yes | Yes | # Of needles | 49 (7 x 7) | 49 (7 x 7) or 16 (4 x 4) | 10 (5 pairs of 2) | | ElectricalRating | Single phase 100-240V, 3A,50/60Hz | Single phase AC220-230V, 50-60Hz Power consumption: 500VA (Fuse: 250V/6.3A) | Single phase 100-240 VAC, 3A, 50-60Hz | Single phase 100-240 V, 2.5A,50-60Hz | # Of treatment levels per insertion | 1, 2 or 3 | 1 | 1 | | User Interface | Graphics with touchscreen | Graphics with touchscreen | Graphics with touchscreen | Graphics with touchscreen | # Of treatment zones per insertion | 49, 98, or 147 | 49 | 5 | | Applicators | Matrix Pro (RF microneedles) Sublative Sublime | RF microneedles | Sublative Sublime | Dermal RF Subcutaneous RF | Maximum RF power | 50 W | 50 W | 15 W | | Treatment Modes | Matrix Pro - Manual Sublative - Manual Sublime - Manual | Manual and Auto | Sublative – Manual Sublime – Manual | Dermal – Manual Subcutaneous – Manual | Energy delivered per treatment level | 1 - 4 J | 25 mJ – 50 J 1 – 20 Levels* | Unknown | | RF Energy Activation | Fingerswitch or Footswitch | Fingerswitch or Footswitch | Fingerswitch | Fingerswitch | Energy delivered per treatment zone | 20 – 82 mJ | 0.51 mJ – 1.02 J | Unknown | | Treatment Settings | Matrix Pro – needle depth and RF energy Sublative - RF energy per pin Sublime - RF power density and IR fluence | Manual mode – needle depth, RF level (power), and RF pulse duration. Auto mode — Location (Lower face Submental, Neck, Forehead, Periorbital), Pass (1 to 3), Intensity (Low, Medium, | Sublative - RF energy per pin Sublime – RF power density and IR fluence | Dermal, Subcutaneous – Treatment temperature and treatment time | Controlled energy delivered | Yes, Controlled by sampling impedance | No Not controlled | No Not controlled | | Controlled thermal dose | No | No | Yes, PID temperature control 50-75°C ±10°C with treatment duration of 3-5 seconds | | | | | | | Repetition Rate** | No existing setting | No existing setting | No existing setting | | | | | | | Needle uncoated | 0.6 mm | 0.3 mm | 3 mm | | | | | | ## Table 8-1: SYSTEM LEVEL - Technical Comparison of Subject System Device with Predicate and Reference Devices {6}------------------------------------------------ # 510(k) Summary – K211217 {7}------------------------------------------------ ## 510(k) Summary – K211217 ## Table 8-2: HANDPIECE AND CARTRIDGE LEVEL - Technical Comparison of Subject Device with Predicate and Reference Devices {8}------------------------------------------------ # 510(k) Summary – K211217 | Specifications | Profound Matrix- Matrix Pro (Subject Device) | Infini Infini Handpiece K121481 (Predicate Device) | Profound Profound Dermal K161043 (Reference Device #2) | | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | Needle insertion angle to tissue | 90° | 90° | 25° | | | | Insertion depth range | 0.8 - 3.5 mm Steps of 0.8 mm | 0.5 - 3.5 mm Recommended steps of at least 0.5 mm | 2 mm | | | Accuracy of insertion depth | ±0.4 mm | Unknown | Unknown | | Needle Thickness / Diameter | | 34 gauge 160 μm | 32 gauge 200 μm | 32 gauge 200 μm | | Treatment Duration | Up to 4.5 sec | 10-400 ms (10 ms steps) 400-1000 ms (50 ms steps) | 5 sec ±0.2 sec increments | | | Rated Voltage | 275 Vrms | Unknown | 84 Vrms | | | Mode of Operation | Microneedles are inserted into the dermis where they emit bipolar RF energy from their electrode needle tips, thermally damaging surrounding tissue and stimulating a tissue healing process. | Microneedles are inserted into the dermis where they emit bipolar RF energy from their electrode needle tips, thermally damaging surrounding tissue and stimulating a tissue healing process | Microneedles are inserted into the dermis where they emit bipolar RF energy from their electrode needle tips, thermally damaging surrounding tissue and stimulating a tissue healing process | | *Level is defined by Intensity/Rate of Heating (Level 5 is equivalent to 9.58 W with a 300-ohm impedance) **Repetition Rate is defined as preset period between needle withdrawal and the next needle insertion {9}------------------------------------------------ | Specifications | Profound Matrix Sublative RF (Subject device) | eTwo Skin Treatment System Sublative RF K141507 (Reference Device #1) | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Energy Type | RF | RF | | Applicator Dimensions | 15 x 16 cm / 5.9 x 6.3" [W x H] | 15 x 16 cm / 5.9 x 6.3" [W x H] | | Applicator Weight | 0.5 kg. / 1.1 lbs. | 0.5 kg. / 1.1 lbs. | | RF Frequency | 1 MHz | 1 MHz | | Power Range | 14-55 W | 14-55 W | | Treatment Area | 64 pin Tip 12 x 12 mm -or- 44 pin Tip 3 x 11 mm | 64 pin Tip 12 x 12 mm -or- 44 pin Tip 3 x 11 mm | | Pulse Duration | Up to 500 ms | Up to 500 ms | | Total RF Energy | Up to 100mJ/pin | Up to 100mJ/pin | | Applicator Dimensions | 15 x 16 cm | 15 x 16 cm | | Disposable Tip Matrix | 44 or 64 matrix pins | 44 or 64 matrix pins | | RF Energy Penetration depth | Up to 400 µm | Up to 400 µm | | Disposable Treatment Tip Lifetime | Up to 400 pulses | Up to 400 pulses | | Rated Voltage | 275 Vrms | 275 Vrms | | Mode of operation | During treatment, the multi- electrodepin array is placed on the dry skin's surface. The RF current flows betweenthe rows of the pins, having the highest impact at the electrode-skin contact points where it creates spots of demarcated ablation and resurfacing of the skin (stratum corneum, the deeper epidermis and superficial dermis) to achieve wrinkle | During treatment, the multi- electrodepin array is placed on the dry skin's surface. The RF current flows betweenthe rows of the pins, having the highest impact at the electrode-skin contact points where it creates spots of demarcated ablation and resurfacing of the skin (stratum corneum, the deeper epidermis and superficial dermis) to achieve wrinkle | ## Table 8-3: Comparison of parameters for Profound Matrix System's Sublative RF applicator and eTwo System's Sublative applicator {10}------------------------------------------------ | Specifications | Profound Matrix Sublime (Subject Device) | eTwo Skin Treatment System Sublime (Refirme) K141507 (Reference Device #1) | |-----------------------|------------------------------------------------|-------------------------------------------------------------------------------------| | Energy Type | RF and IR | RF and IR | | Applicator Dimensions | 20 x 20 cm / 7.8 x 7.8" | 20 x 20 cm / 7.8 x 7.8" | | | [W x H] | [W x H] | | Applicator Weight | 1.0 kg. / 2.2 lbs. | 1.0 kg. / 2.2 lbs. | | Frequency | 1 MHz | 1 MHz | | RF Power | 200 W (≤138.9 W/cm2) | 200 W (≤138.9 W/cm2) | | | | | | Treatment Area | 8 x 12 mm | 8 x 12 mm | | Pulse Duration | Up to 200 ms | Up to 200 ms | | Total RF Energy | Hz Mode: 50-200 J/cm3 | Hz Mode: 50-200 J/cm3 | | | Hz Mode: 50-100 J/cm3 | Hz Mode…