Resonic Rapid Acoustic Pulse Device

K212502 · Soliton, Inc. · GEX · Nov 5, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K212502
• Device Name: Resonic Rapid Acoustic Pulse Device
• Applicant: Soliton, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 5, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Device uses rapid acoustic pulses to improve laser tattoo fading and cellulite appearance. For tattoos, acoustic waves dissipate laser-induced microbubble whitening, allowing multiple laser passes per session. For cellulite, acoustic waves disrupt fibrous septa in subcutaneous tissue. System comprises console, cable, and handpiece; console supplies saline to handpiece to generate shock waves via rapid water heating. Operated by clinicians in clinical settings. Output is acoustic shock wave delivered through hydrogel pad on skin. Benefits include accelerated tattoo fading, fewer office visits, and long-term cellulite improvement.

Clinical Evidence

Single-arm, prospective, multi-site trial (n=67). Participants received one treatment session on buttock/thigh. Primary endpoint: blinded physician panel identification of post-treatment photos at 52 weeks. Results: 95.2% correct identification; mean cellulite severity score reduction of 1.09. 97.6% of participants reported good improvement at 52 weeks. No device-related serious adverse events reported. Data supports long-term treatment effect maintenance through 1 year.

Technological Characteristics

Console, cable, handpiece. Acoustic shock wave generation via rapid saline heating. Broadband/ultrasonic frequency; pulsed waveform. Peak fluence 0.0029 J/cm²; peak acoustic pressure 0.25-12 MPa. Tattoo mode: 100 Hz; Cellulite mode: 50 Hz. 38 mm spot size. Compliant with IEC 60601-1 and IEC 60601-1-2. Single-use disposable cartridge. LCD touch screen interface.

Indications for Use

Indicated for black ink tattoo removal (Fitzpatrick Skin Type I-III) as an accessory to 1064 nm Q-Switched laser, and for long-term improvement in cellulite appearance.

Regulatory Classification

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.

Predicate Devices

• Soliton Resonic™ Rapid Acoustic Pulse Device (K210964)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>5304 Ashbrook Drive<br>Houston, TX 77081 | | Soliton Resonic™ Rapid<br>Acoustic Pulse Device<br>(K212502; Subject Device) | Soliton Resonic™ Rapid<br>Acoustic Pulse Device<br>(K210964; Predicate<br>Device) | Comparison |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Contact Person: | Leslie Honda<br>VP, Regulatory Affairs and Quality Systems<br>Tel: [phone] | Indications for<br>Use | The Soliton Resonic ™<br>Rapid Acoustic Pulse<br>device is indicated for use<br>as an accessory to the 1064<br>nm Q-Switched laser for<br>black ink tattoo removal in<br>Fitzpatrick Skin Type I-III<br>patients. The Resonic<br>device is also indicated for<br>long-term improvement in<br>the appearance of cellulite<br>as supported by clinical<br>data demonstrating<br>treatment benefits up to 1<br>year of observation. | The Soliton Resonic ™<br>Rapid Acoustic Pulse device<br>is indicated for use as an<br>accessory to the 1064 nm<br>Q-Switched laser for black<br>ink tattoo removal in<br>Fitzpatrick Skin Type I-III<br>patients. The Resonic<br>device is also indicated for<br>short-term improvement in<br>the appearance of cellulite. | Indications for use updated<br>based on long-term follow-<br>up data. |
| Date Prepared: | October 28, 2021 | Device<br>Technology | Tattoo treatment mode:<br>Acoustic waves to<br>dissipate the opaque<br>"whitening" caused by the<br>microbubbles formed after<br>exposure to Q-switched<br>laser.<br>Cellulite treatment mode:<br>External electrodes to<br>rapidly heat water which<br>produces an acoustic pulse<br>that partially disrupts the<br>fibrous septa to improve<br>cellulite appearance. | Tattoo treatment mode:<br>Acoustic waves to<br>dissipate the opaque<br>"whitening" caused by the<br>microbubbles formed after<br>exposure to Q-switched<br>laser.<br>Cellulite treatment mode:<br>External electrodes to<br>rapidly heat water which<br>produces an acoustic pulse<br>that partially disrupts the<br>fibrous septa to improve<br>cellulite appearance. | Same |
| Trade Name: | Soliton Resonic™ Rapid Acoustic Pulse Device | Acoustic Wave<br>Type | Acoustic shock wave | Acoustic shock wave | Same |
| Common Name: | Dermatology Laser System | | | | |
| Classification: | Class II<br>Laser surgical instrument for use in general and plastic surgery and in<br>dermatology (21 CFR 878.4810)<br>Product Code GEX | | | | |
| Predicate Device: | Soliton Resonic™ Rapid Acoustic Pulse Device (K210964) | | | | |

#### Indications for Use:

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.

## 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 Wave<br>Frequency | Broadband/Ultrasonic | Broadband/Ultrasonic | Same |
|---------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------|
| Repetition rate | Tattoo treatment mode:<br>100 Hz<br>Cellulite treatment mode: 50<br>Hz | Tattoo treatment mode:<br>100 Hz<br>Cellulite treatment mode:<br>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 Acoustic<br>Pressure | 0.25 to 12 MPa | 0.25 to 12 MPa | Same |
| Primary<br>Components | Console<br>Energy Conduit (Cable)<br>Hand piece | Console<br>Energy Conduit (Cable)<br>Hand piece | Same |
| Hand Piece<br>Components | Hand Piece Grip<br>Cartridge | Hand Piece Grip<br>Cartridge | Same |
| Electrical<br>Safety/EMC | IEC 60601-1 Compliant<br>IEC 60601-1-2 Compliant | IEC 60601-1 Compliant<br>IEC 60601-1-2 Compliant | Same |
| Input Power | 240VAC<br>60Hz | 240VAC<br>60Hz | Same |
| Fuse Rating | 15 A | 15 A | Same |
| User Interface | LCD Touch Screen Graphic<br>User Interface | LCD Touch Screen Graphic<br>User Interface | Same |
| System<br>Dimensions | 56" x 17.7" x 13.8" | 56" x 17.7" x 13.8" | Same |
| Weight | 220 lbs. | 220 lbs. | Same |
| Foot Switch<br>Activation | Yes | Yes | Same |
| Single Use<br>Disposable<br>Component | 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.