PL-1 Skin Treatment System

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June 28, 2022 Avava, Inc Jay Bhawalkar Chief Technology Officer 275 Second Avenue, Floor 3 Waltham, Massachusetts 02451 Re: K213726 Trade/Device Name: PL-1 Skin Treatment System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX, ONG Dated: May 25, 2022 Received: May 27, 2022 Dear Jay Bhawalkar: 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 {1}------------------------------------------------ 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) 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, Jianting Wang, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213726 Device Name PL-1 Skin Treatment System #### Indications for Use (Describe) The PL-1 Skin Treatment System is a 1064 nm laser system intended to ablate, vaporize, and coagulate soft body tissues for aesthetic and cosmetic applications in the medical specialties of dermatology and plastic surgery. It is also indicated for removal of benign pigmented lesions including; nevus of Ota, café au lait spot, ephelides, solar lentigines), Becker's nevus, nevus spilus and treatment of common nevi.. The PL-1 Skin Treatment System is intended to be used by medical professionals and staff who are of lasers and who are familiar with the technology, operation of the system, and safety precautions. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ #### General Provisions | 510(k) Owner's Name: | AVAVA, Inc. | |------------------------|-------------------------------------------------------------------------------------| | Address: | 245 Second Avenue, Floor 3 Waltham, MA 02451 | | Contact Person: | Jay Bhawalkar, Ph.D., Chief Technology Officer | | Phone Number: | Office: 617-377-7961 | | Fax Number: | Not applicable | | Classification Name: | Laser Surgical Instrument for Use in General and Plastic<br>Surgery and Dermatology | | Regulation: | 21 CFR 878.4810 | | Regulatory Class: | II | | Product Code: | GEX, ONG | | Proprietary Name: | PL-1 Skin Treatment System | | Common Name: | Powered Laser Surgical Instrument with Microbeam Output | | Date Summary Prepared: | May 26, 2022 | #### Name of Predicate Device(s) - Primary Predicate: Quanta Chrome, K202503 #### Intended Use The PL-1 Skin Treatment System is a 1064 nm laser system intended to ablate, vaporize, and coagulate soft body tissues for aesthetic and cosmetic applications in the medical specialties of dermatology and plastic surgery. It is also indicated for removal of benign pigmented lesions including; nevus of Ota, café au lait spot, ephelides, solar lentigines), Becker's nevus, nevus spilus and treatment of common nevi. The PL-1 Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. #### Device Description The PL-1 Skin Treatment System is a 1064nm, Q-switched laser system. The system includes three (3) main components: Console, Tablet, and Handpiece. The Console houses the system control electronics, power distribution, contact cooling, and laser. The primary user interface for controlling the system through a touch screen graphical user interface. The Handpiece contains the optics, focusing components, and reference window assembly. The PL-1 Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Handpiece on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The device is intended to be used by a suitably trained professional in a clinical setting. There are no sterile components. {4}------------------------------------------------ #### Technological Characteristics The PL-1 Skin Treatment System has the same intended use and similar indications for use, technological characteristics and operating principles as the Quanta Chrome system (Quanta systems) operating in the 1064 Q-switched, nanosecond mode with a microbeam handpiece. The design and components are very similar to the Quanta systemas shown in the following table. The differences are minor and do not raise any new issues of safety or efficacy of the PL-1 Skin Treatment System device as shown in the performance testing results. | Characteristic | Subject Device | Primary Predicate | Substantial<br>Equivalence? | |-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | PL-1 Skin Treatment System | Chrome | NA | | Manufacturer | AVAVA | Quanta | NA | | 510k | K213726 | K202503 | NA | | Classification | 878.4810 Laser surgical<br>instrument for use in general<br>and plastic surgery and in<br>dermatology | 878.4810 Laser surgical<br>instrument for use in general<br>and plastic surgery and in<br>dermatology | Yes, same classification | | Product code | GEX, ONG | GEX | Yes, same code | | Device class | II | II | Yes, same class | | Intended use | Aesthetic and cosmetic<br>applications requiring ablation,<br>vaporization and coagulation of<br>body soft tissues in the medical<br>specialties of dermatology and<br>plastic surgery | Aesthetic, cosmetic and surgical<br>applications requiring incision,<br>excision, ablation, vaporization and<br>coagulation of body soft tissues in<br>the medical specialties of<br>dermatology, general, plastic and<br>oral surgery | Yes, same intended use<br>for aesthetic and cosmetic<br>applications | | Indications | The PL-1 Skin Treatment system<br>is indicated for the removal of<br>benign pigmented lesions<br>including; nevus of Ota, café au<br>lait spot, ephelides, solar<br>lentigo (lentigines), Becker's<br>nevus, nevus spilus, and<br>treatment of common nevi. | The Quanta Chrome system<br>operating in 1064nm<br>nanosecond mode with<br>microbeam handpiece is<br>indicated for: Removal of dark<br>ink (black, blue and brown)<br>tattoos. Removal of benign<br>pigmented lesions including;<br>nevus of Ota, Café au lait spot,<br>Ephalides, solar lentigo<br>(lentigines), Becker Nevus,<br>Nevus spilus. Treatment of<br>common nevi. Removal or<br>lightening of unwanted hair Skin<br>resurfacing procedures for the<br>treatment of acne scars and<br>wrinkles. | Yes, same indication<br>for use for BPL based<br>on equivalence in<br>operating principle,<br>laser type, wavelength,<br>treatment parameters<br>and demonstrated<br>performance to<br>specifications | | Characteristic | Subject Device | Primary Predicate | Substantial<br>Equivalence? | | Operating Principles | | | | | Focused<br>microbeams | Yes | Yes | Yes | | Mechanism | Selective photothermolysis | Selective photothermolysis | Yes | | Laser | | | | | CDRH Laser Classification | Class 4 | Class 4 | Yes | | Q-switched flash lamp<br>pumped laser | Yes | Yes | Yes | | Wavelength (nm) | 1064 | 1064 | Yes | | Maximum pulse energy<br>(mJ) | 850 | 800 | Yes, difference of 6% is<br>well under acceptable<br>tolerance of 20% for<br>single system per IEC<br>60601-2-22 | | Nominal pulse width (ns) | 6 to 12 | 6 to 12 | Yes | | Pulse repetition rate,<br>maximum (Hz) | 10 | 20 | Yes , repetition rate for<br>the subject device is a<br>subset of the cleared<br>specification for the<br>predicate device | | Aiming beam | None | 635 nm | Yes, position at<br>intended treatment<br>site achieved through<br>specified means. | | Treatment | | | | | Optics | Focusing optics in<br>handpiece | Focusing optics in<br>handpiece | Yes, similar delivery of<br>focused laser energy | | Tissue contact | Reference window | Distance gauge | Yes, treatment distance is<br>maintained through<br>specified means | | Cooling mechanism | None | Integrated skin cooler for<br>optional use prior to laser<br>treatment | Yes, optional for<br>predicate system. | | Energy delivery | Microbeam | Microbeam | Yes | | Number of microbeams | 60 | 66 | Yes, similar number of<br>microbeams covering<br>same spot dimension | | Spot diameter (mm) | 8 mm round | 8 mm round | Yes | | Max fluence per<br>microbeam (J/cm²) | Up to 45 | Up to 44 | Yes | | Output verification | Bench testing | Bench testing | Yes | | Device<br>Characteristics | | | | | User interface | Touchscreen | Touchscreen | Yes | | Characteristic | Subject Device | Primary Predicate | Substantial<br>Equivalence? | | Software Control | Yes | Yes | Yes | | Laser trigger | Foot switch | Foot switch | Yes | | Emergency shut-off | Yes | Yes | Yes | | Safety | | | | | FDA CDRH 21 CFR 1040 | Yes | Yes | Yes | | Electrical safety<br>(IEC 60601-1) | Yes | Yes | Yes | | Electromagnetic<br>compatibility<br>(IEC 60601-1-2) | Yes | Yes | Yes | {5}------------------------------------------------ {6}------------------------------------------------ #### Risk Analysis Risk analysis was performed according to IEC 14971:2007 Medical Devices- Application of Risk Management to Medical Devices, reviewed by a nationally recognized testing laboratory (NRTL), and found to be in compliance. #### Summary of Performance Testing Electrical Safety, Electromagnetic Compatibility, Biocompatibility and Laser Safety Evaluation of the device was conducted by a nationally recognized testing laboratory (NRTL) and was found in compliance with the following standards: - IEC 60601-1-2:2014 Ed 4.0 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical electrical . equipment - Part 1: General requirements for basic safety and essential performance - IEC 62304:2006 + A1:2015, Ed. 1.0 Medical device software Software life cycle ● processes - IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment Part 1-6: . General requirements for basic safety and essential performance - Collateral standard: Usability {7}------------------------------------------------ - IEC 62366-1: 2015 Medical devices Part 1: Application of usability engineering . to medical devices - IEC 60601-2-22: 2019 Medical electrical equipment Part 2-22: Particular . requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment - . IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements - ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process ## Non-Clinical Performance Data The PL-1 Skin Treatment System performance characteristics have been evaluated through usability testing compliant to FDA Guidance Applying Human Factors and Usability Enqineering to Medical Devices (2016) and IEC 62366-1, and verification and validation of the PL-1 Skin Treatment System's laser energy, performance and control mechanisms. The performance of the PL-1 Skin Treatment System and related parameters of the predicate devices are substantially equivalent. Software verification and validation testing was conducted, and documentation provided as recommended by FDA Guidance Content of Premarket Submissions for Software Contained in Medical Devices (2005) and IEC 62304. Device software verification and validation results were found acceptable for software release. Biocompatibility of the patient contacting materials was established per FDA Guidance Use of International Standard ISO 10993-1 Biological evaluation of medical devices –Part 1: Evaluation and Testing Within a Risk Management Process (2018) and the referenced standard. Animal studies and clinical performance testing were not deemed necessary as the device is using the same key technology, operating principles, and intended use as the predicate device. {8}------------------------------------------------ ### Summary of Substantial Equivalence The PL-1 Skin Treatment System and the predicate devices have the same intended use for the 1064 Q-switched nanosecond mode with microbeam handpiece. The PL-1 Skin Treatment System presents similar technological characteristics as its predicate devices, including the laser type, wavelength, and device design. Although there are minor differences in the details of the device design, they are not sufficient to raise new questions of safety or efficacy. #### Conclusion The PL-1 Skin Treatment System is as safe and effective as the predicate devices operating in the 1064 Q-switched nanosecond mode with a microbeam handpiece. The new device has similar intended use and indications for use, technological characteristics and the same principle of operation as the predicate devices. The minor design differences raise no new issues of safety or efficacy as demonstrated by the performance data. The data show that the PL-1 Skin Treatment System performs in accordance with its specifications and requirements for both safety and effectiveness in similarity to the predicate devices. Thus, the PL-1 Skin Treatment System and the predicates are substantially equivalent.