Resonic Rapid Acoustic Pulse Device

K210964 · Soliton, Inc. · GEX · Apr 27, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210964
• Device Name: Resonic Rapid Acoustic Pulse Device
• Applicant: Soliton, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 27, 2021
• Decision: SESE
• Submission Type: Special
• 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 Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for short-term improvement in the appearance of cellulite.

Device Story

Resonic Rapid Acoustic Pulse device generates acoustic shock waves to assist in tattoo removal and cellulite treatment. System comprises console, handpiece, and connecting cable. Console supplies saline to handpiece; handpiece generates acoustic waves within an internal chamber. Waves propagate through an acoustically transparent window and hydrogel pad placed against patient skin. Device used in clinical settings by trained operators. Acoustic pulses facilitate tattoo ink clearance when used with 1064 nm Q-Switched lasers and provide short-term aesthetic improvement for cellulite. Device is a modified version of previously cleared technology (K201801) with minor hardware/software updates; fundamental scientific technology, wave frequency, and repetition rates remain unchanged.

Clinical Evidence

Bench testing only. Verification testing confirmed device functions as specified. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2. Biocompatibility established via predicate evaluation; no new patient-contact materials. Software verification testing completed.

Technological Characteristics

System includes console, handpiece, and cable. Operates via acoustic shock wave generation in saline. Interface uses acoustically transparent window and hydrogel pad. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC).

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 short-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 Rapid Acoustic Pulse Device (K201801)

Submission Summary (Full Text)

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April 27, 2021

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

Re: K210964

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: March 31, 2021 Received: March 31, 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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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

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

510(k) Number (if known)

K210964

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 Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for shortterm improvement in the appearance of cellulite.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) SUMMARY

#### Soliton Resonic™ Rapid Acoustic Pulse Device

| Submitted by: | Soliton, Inc.<br>5304 Ashbrook Drive<br>Houston, TX 77081 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leslie Honda<br>VP, Regulatory Affairs and Quality Systems<br>Tel: [phone] |
| Date Prepared: | March 31, 2021 |
| Trade Name: | Soliton Resonic™ Rapid Acoustic Pulse Device |
| 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 Devices: | Soliton Rapid Acoustic Pulse Device (K201801) |

#### 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 Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for short-term improvement in the appearance of cellulite.

#### 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 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 Resonic RAP is a modification to the company's Rapid Acoustic Pulse (RAP) device that has already been cleared for the same indications for use (K201801). Only minor hardware and software changes have been made. These changes do not alter the fundamental scientific technology of the modified device. Specifically, the shape, frequency and repeition rate of the acoustic waves are not changed.

#### Performance Data:

In accordance with Soliton's design control procedures, risk analysis was conducted to assess the impact of the modifications on the device. Verification testing using the same methods as

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used for the predicate device demonstrates that the Resonic RAP device functions as specified and is as safe and effective as its predicate device.

Electrical safety and electromagnetic compatibility (EMC) testing was repeated for the Resonic RAP device by an independent test laboratory in accordance with IEC 60601-1, 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 Resonic RAP device is established based on the evaluation of the RAP. No new materials are used on the surface of the device that contacts the patient skin.

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

### Conclusions:

The Resonic RAP device is as safe and effective as the predicate RAP device previously cleared in K201801. The Resonic RAP device and its predicate device have the same intended use and indications for use, and similar technological characteristics and principles of operation. The minor differences in the newer device version (the subject device) do not alter the fundamental technological characteristics or present different questions of safety or effectiveness as compared to the predicate device. Thus, The Resonic RAP device is substantially equivalent to the predicate device.