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.

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.

AI/ML Overview

The provided regulatory document (K213726) for the PL-1 Skin Treatment System focuses on demonstrating substantial equivalence to a predicate device (Quanta Chrome, K202503) rather than presenting a clinical study where the device performance is measured against specific acceptance criteria.

The document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/algorithm-driven device with ground truth establishment, expert adjudication, or MRMC studies.

Instead, it asserts substantial equivalence based on:

Same intended use and similar indications for use.
Similar technological characteristics and operating principles (e.g., laser type, wavelength, mechanism of action, focused microbeams).
Performance testing for safety and basic functionality compliant with established standards, such as electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software life cycle processes (IEC 62304), usability (IEC 60601-1-6, IEC 62366-1), and laser specific safety (IEC 60601-2-22, IEC 60825-1).
Biocompatibility (ISO 10993-1).

The document explicitly states: "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." This indicates that a study with the characteristics typically seen for AI/algorithm-driven medical devices (like those requiring test sets, expert ground truth, MRMC studies) was not conducted for this 510(k) submission.

Therefore, I cannot provide a table of acceptance criteria and proven device performance, nor can I answer points 2 through 9, as this information is not present in the provided text. The submission relied on demonstrating technological equivalence and compliance with relevant safety and performance standards for a laser device, not on clinical performance metrics with a test set and associated ground truth.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 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)
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}------------------------------------------------

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 PlasticSurgery 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

{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	SubstantialEquivalence?
Device	PL-1 Skin Treatment System	Chrome	NA
Manufacturer	AVAVA	Quanta	NA
510k	K213726	K202503	NA
Classification	878.4810 Laser surgicalinstrument for use in generaland plastic surgery and indermatology	878.4810 Laser surgicalinstrument for use in generaland plastic surgery and indermatology	Yes, same classification
Product code	GEX, ONG	GEX	Yes, same code
Device class	II	II	Yes, same class
Intended use	Aesthetic and cosmeticapplications requiring ablation,vaporization and coagulation ofbody soft tissues in the medicalspecialties of dermatology andplastic surgery	Aesthetic, cosmetic and surgicalapplications requiring incision,excision, ablation, vaporization andcoagulation of body soft tissues inthe medical specialties ofdermatology, general, plastic andoral surgery	Yes, same intended usefor aesthetic and cosmeticapplications
Indications	The PL-1 Skin Treatment systemis indicated for the removal ofbenign pigmented lesionsincluding; nevus of Ota, café aulait spot, ephelides, solarlentigo (lentigines), Becker'snevus, nevus spilus, andtreatment of common nevi.	The Quanta Chrome systemoperating in 1064nmnanosecond mode withmicrobeam handpiece isindicated for: Removal of darkink (black, blue and brown)tattoos. Removal of benignpigmented lesions including;nevus of Ota, Café au lait spot,Ephalides, solar lentigo(lentigines), Becker Nevus,Nevus spilus. Treatment ofcommon nevi. Removal orlightening of unwanted hair Skinresurfacing procedures for thetreatment of acne scars andwrinkles.	Yes, same indicationfor use for BPL basedon equivalence inoperating principle,laser type, wavelength,treatment parametersand demonstratedperformance tospecifications
Characteristic	Subject Device	Primary Predicate	SubstantialEquivalence?
Operating Principles
Focusedmicrobeams	Yes	Yes	Yes
Mechanism	Selective photothermolysis	Selective photothermolysis	Yes
Laser
CDRH Laser Classification	Class 4	Class 4	Yes
Q-switched flash lamppumped laser	Yes	Yes	Yes
Wavelength (nm)	1064	1064	Yes
Maximum pulse energy(mJ)	850	800	Yes, difference of 6% iswell under acceptabletolerance of 20% forsingle system per IEC60601-2-22
Nominal pulse width (ns)	6 to 12	6 to 12	Yes
Pulse repetition rate,maximum (Hz)	10	20	Yes , repetition rate forthe subject device is asubset of the clearedspecification for thepredicate device
Aiming beam	None	635 nm	Yes, position atintended treatmentsite achieved throughspecified means.
Treatment
Optics	Focusing optics inhandpiece	Focusing optics inhandpiece	Yes, similar delivery offocused laser energy
Tissue contact	Reference window	Distance gauge	Yes, treatment distance ismaintained throughspecified means
Cooling mechanism	None	Integrated skin cooler foroptional use prior to lasertreatment	Yes, optional forpredicate system.
Energy delivery	Microbeam	Microbeam	Yes
Number of microbeams	60	66	Yes, similar number ofmicrobeams coveringsame spot dimension
Spot diameter (mm)	8 mm round	8 mm round	Yes
Max fluence permicrobeam (J/cm²)	Up to 45	Up to 44	Yes
Output verification	Bench testing	Bench testing	Yes
DeviceCharacteristics
User interface	Touchscreen	Touchscreen	Yes
Characteristic	Subject Device	Primary Predicate	SubstantialEquivalence?
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(IEC 60601-1)	Yes	Yes	Yes
Electromagneticcompatibility(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.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.