The Soliton Resonic™ Rapid Acoustic Pulse device is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to 1 year of observation.

Device Description

The Soliton Resonic™ Rapid Acoustic Pulse device is designed as an accessory to laser treatments to improve laser tattoo fading efficiency, as well as a standalone device to improve the appearance of cellulite. Resonic uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laser-induced whitening. This allows multiple laser passes in a single session, resulting in accelerated tattoo fading and fewer office visits to achieve sufficient tattoo fading. When used for improving the appearance of cellulite, the acoustic waves induce physical effects in the fibrous structures, such as the fibrous septa in the subcutaneous tissue.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Soliton Resonic™ Rapid Acoustic Pulse Device
Intended Use: Long-term improvement in the appearance of cellulite.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Effectiveness)	Reported Device Performance
Primary Effectiveness Endpoint: A blinded physician panel correctly identifies long-term (>52-weeks) post-treatment photographs. (Specific threshold for correct identification is not explicitly stated as a percentage in the acceptance criteria, but implied by the reported performance).	The blinded physician panel correctly identified the long-term (>52-weeks) post-treatment photograph in 95.2% of the cases.
Mean Cellulite Severity Score Reduction: (Specific target reduction not explicitly stated, but implied as a measure of improvement).	The mean cellulite severity score reduction was 1.09.
Patient Satisfaction (at 52 weeks): Implied, as the study collected patient satisfaction responses and aimed to demonstrate maintained treatment benefits. (Specific percentage target not explicitly stated in acceptance criteria).	At 52 weeks, all participants found their treatment areas to appear improved compared to the pre-treatment photos, and 97.6% of participants found there was good improvement in the appearance of cellulite.
Safety: No significant adverse events, or only mild/moderate expected adverse events. (Implied, as safety is always a key consideration for medical devices).	All adverse events observed were categorized as mild or moderate and were expected. No adverse events were related to the device. There were no serious adverse events.
Long-Term Improvement: Demonstrates no significant reduction in treatment benefits up to 1 year of observation. (This is the overarching acceptance criteria for the new indication).	The reported performance data (95.2% correct identification, 1.09 mean severity reduction, high patient satisfaction, and maintained safety profile) collectively demonstrates that the treatment effect with Resonic RAP device in improving the appearance of cellulite is maintained through 1 year after the treatment.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for the Test Set: A total of 67 participants were enrolled.
Data Provenance:
- Country of Origin: United States (4 sites in the United States).
- Retrospective or Prospective: Prospective multi-site trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: "Blinded independent reviewers" and "blinded physician panel." The exact number of individuals on the panel is not specified in this document.
Qualifications of Experts: They were described as "blinded independent reviewers" and "blinded physician panel." While the specific medical specialty (e.g., dermatologist) or years of experience are not explicitly stated, the term "physician panel" implies qualified medical professionals.

4. Adjudication Method for the Test Set

The adjudication method is implied as "blinded independent reviewers" or a "blinded physician panel" assessing photographs. The specific scheme (e.g., 2+1, 3+1) for resolving disagreements among multiple reviewers is not explicitly stated. It just mentions they "assessed by blinded independent reviewers to identify pre-treatment images when compared to post treatment images."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study comparing human readers with vs. without AI assistance was not done.

This study focused on the effectiveness of the device itself (Resonic RAP) for improving cellulite appearance, as assessed by a blinded physician panel, not on human reader performance assisted by the device or AI. The device is not an AI diagnostic tool that "assists" human readers in making diagnoses. It's a treatment device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable in the conventional sense for an AI device. The Resonic RAP device is a physical acoustic pulse device, not an AI algorithm. Its performance is inherent in its physical operation, not an output from a standalone algorithm. The "standalone" aspect in this context refers to its use as a "standalone device to improve the appearance of cellulite" as opposed to an accessory for tattoo removal, but this is a treatment application, not a diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for effectiveness was established by:

Expert Consensus/Assessment: Assessment of serial clinical photographs by a "blinded independent reviewers" or "blinded physician panel" to identify post-treatment images and evaluate cellulite severity reduction.
Patient Reported Outcomes: Patient satisfaction surveys were used to assess participants' perception of improvement.

8. The Sample Size for the Training Set

Not applicable/Not provided within this document. This document describes a clinical study for a physical medical device (Resonic RAP), not the development or validation of a machine learning algorithm that requires a separate training set. The "training set" concept is typically relevant for AI/ML devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As explained above, this document does not describe the development of an AI/ML algorithm with a training set.

Summary

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November 5, 2021

Soliton Inc. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103

Re: K212502

Trade/Device Name: Resonic Rapid Acoustic Pulse Device 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 Dated: August 9, 2021 Received: August 9, 2021

Dear Janice Hogan:

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.

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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) 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.

Purva Pandya 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

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below

510(k) Number (if known)

K212502

Device Name

Resonic™ Rapid Acoustic Pulse device Indications for Use (Describe)

The Soliton Resonic™ Rapid Acoustic Pulse device is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatick Skin Type I-III patients. The Resoric device for longterm improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to 1 vear of observation.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Soliton Resonic™ Rapid Acoustic Pulse Device

K212502

Submitted by:	Soliton, Inc.5304 Ashbrook DriveHouston, TX 77081		Soliton Resonic™ RapidAcoustic Pulse Device(K212502; Subject Device)	Soliton Resonic™ RapidAcoustic Pulse Device(K210964; PredicateDevice)	Comparison
Contact Person:	Leslie HondaVP, Regulatory Affairs and Quality SystemsTel: 206.375.8586	Indications forUse	The Soliton Resonic ™Rapid Acoustic Pulsedevice is indicated for useas an accessory to the 1064nm Q-Switched laser forblack ink tattoo removal inFitzpatrick Skin Type I-IIIpatients. The Resonicdevice is also indicated forlong-term improvement inthe appearance of celluliteas supported by clinicaldata demonstratingtreatment benefits up to 1year of observation.	The Soliton Resonic ™Rapid Acoustic Pulse deviceis indicated for use as anaccessory to the 1064 nmQ-Switched laser for blackink tattoo removal inFitzpatrick Skin Type I-IIIpatients. The Resonicdevice is also indicated forshort-term improvement inthe appearance of cellulite.	Indications for use updatedbased on long-term follow-up data.
Date Prepared:	October 28, 2021	DeviceTechnology	Tattoo treatment mode:Acoustic waves todissipate the opaque"whitening" caused by themicrobubbles formed afterexposure to Q-switchedlaser.Cellulite treatment mode:External electrodes torapidly heat water whichproduces an acoustic pulsethat partially disrupts thefibrous septa to improvecellulite appearance.	Tattoo treatment mode:Acoustic waves todissipate the opaque"whitening" caused by themicrobubbles formed afterexposure to Q-switchedlaser.Cellulite treatment mode:External electrodes torapidly heat water whichproduces an acoustic pulsethat partially disrupts thefibrous septa to improvecellulite appearance.	Same
Trade Name:	Soliton Resonic™ Rapid Acoustic Pulse Device	Acoustic WaveType	Acoustic shock wave	Acoustic shock wave	Same
Common Name:	Dermatology Laser System
Classification:	Class IILaser surgical instrument for use in general and plastic surgery and indermatology (21 CFR 878.4810)Product Code GEX
Predicate Device:	Soliton Resonic™ Rapid Acoustic Pulse Device (K210964)

Indications for Use:

Device Description:

Summary of Technological Characteristics:

The Soliton Resonic™ Rapid Acoustic Pulse device is composed of three parts: the Console, the Hand Piece and the Cable connecting the Hand Piece to the Console. The Console supplies saline to the Hand Piece to enable formation of the shock wave within the acoustic pulse chamber. The Hand Piece generates acoustic waves in the saline. The acoustic waves

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pass through the acoustically transparent window and acoustic ultrasound gel or similar hydrogel pad, which when placed against the surface of the skin to be treated.

The subject RAP device is almost identical to the previously cleared Resonic device. The primary purpose of this submission is to update the indications for use to reflect the long-term clinical data through one year. With respect to the technology, only minor changes have been made. These changes do not alter the scientific technology or the use of the modified device. Specifically, the shape, frequency and repetition rate of the acoustic waves are not changed.

Substantial Equivalence Comparison Table

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Acoustic WaveFrequency	Broadband/Ultrasonic	Broadband/Ultrasonic	Same
Repetition rate	Tattoo treatment mode:100 HzCellulite treatment mode: 50Hz	Tattoo treatment mode:100 HzCellulite treatment mode:50 Hz	Same
Waveform	Pulsed	Pulsed	Same
Spot Size	38 mm	38 mm	Same
Peak Fluence	0.0029 J/cm²	0.0029 J/cm²	Same
Peak AcousticPressure	0.25 to 12 MPa	0.25 to 12 MPa	Same
PrimaryComponents	ConsoleEnergy Conduit (Cable)Hand piece	ConsoleEnergy Conduit (Cable)Hand piece	Same
Hand PieceComponents	Hand Piece GripCartridge	Hand Piece GripCartridge	Same
ElectricalSafety/EMC	IEC 60601-1 CompliantIEC 60601-1-2 Compliant	IEC 60601-1 CompliantIEC 60601-1-2 Compliant	Same
Input Power	240VAC60Hz	240VAC60Hz	Same
Fuse Rating	15 A	15 A	Same
User Interface	LCD Touch Screen GraphicUser Interface	LCD Touch Screen GraphicUser Interface	Same
SystemDimensions	56" x 17.7" x 13.8"	56" x 17.7" x 13.8"	Same
Weight	220 lbs.	220 lbs.	Same
Foot SwitchActivation	Yes	Yes	Same
Single UseDisposableComponent	Cartridge	Cartridge	Same

Performance Data:

Electrical safety and electromagnetic compatibility (EMC) testing was performed for the Resonic RAP device by an independent test laboratory in accordance with IEC 60601-1,

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Medical electrical equipment, Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

The biocompatibility of the Resonic RAP device is established based on the evaluation of the previous version of the device as there is no change to the patient contacting components.

Software verification testing was conducted and the testing results were found acceptable for software release.

All performance testing demonstrated that Resonic RAP performs according to specifications and functions as intended.

Clinical Study Data:

The Resonic RAP device was evaluated in a single arm, self-controlled, prospective, multi-site trial to assess the safety and effectiveness of the device for its indicated use for the improvement in the appearance of cellulite. A total of 67 participants were enrolled at 4 sites in the United States and received one treatment session on the buttock and/or thigh areas. The mean age was 43 years and the majority of the participants were Caucasian.

All treatment sites were treated with multiple 1-minute doses of RAP to cover the site. Serial clinical photographs were collected under standardized conditions before treatment (baseline) and at the 12-week and 52-week follow-up visits. Photographs were assessed by blinded independent reviewers to identify pre-treatment images when compared to post treatment images. Patient satisfaction was assessed by participants' responses to the satisfaction survey. Safety assessments included evaluation of AEs via physician examination during and after the treatment.

The 12-week results were previously submitted in K201801 to support the indicated use of the device for the short-term improvement in the appearance of cellulite. The 52-week results are now provided to support the long-term improvement by demonstrating no significant reduction in treatment benefits up to 1 year of observation.

The primary effectiveness endpoint of the long-term study was met as the blinded physician panel correctly identified the long-term (>52-weeks) post-treatment photograph in 95.2% of the cases. The mean cellulite severity score reduction was 1.09. At 52 weeks, all participants found their treatment areas to appear improved compared to the pre-treatment photos, and 97.6% of participants found there was good improvement in the appearance of cellulite.

The safety of the Resonic RAP device was evaluated based on the adverse events reported during the study. All adverse events observed were categorized as mild or moderate and were expected. No adverse events were related to the device. There were no serious adverse events.

The study results demonstrated that the treatment effect with Resonic RAP device in improving the appearance of cellulite is maintained through 1 year after the treatment.

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Conclusions:

Resonic RAP and its predicate device have the same intended use and similar indications for use, technological characteristics and principles of operation. The minor differences in the technological characteristics do not present different questions of safety or effectiveness as compared to the predicate device. Nonclinical testing of the device demonstrated that the device performs as intended. Clinical testing confirms that the treatment effect with the device in improving the appearance of cellulite is maintained through one year after the treatment. Therefore, Resonic RAP is substantially equivalent to the predicate device.

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.