(27 days)
Not Found
No
The summary describes a device that uses acoustic pulses for tattoo removal and cellulite treatment. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on safety, effectiveness compared to a predicate device, electrical safety, EMC, biocompatibility, and software verification, none of which indicate the presence of AI/ML.
Yes
The device is indicated for medical conditions such as black ink tattoo removal and short-term improvement in the appearance of cellulite, which are therapeutic interventions.
No
The device's stated indications for use are "tattoo removal" and "short-term improvement in the appearance of cellulite," which are therapeutic or aesthetic applications, not diagnostic ones.
No
The device description clearly outlines hardware components: a Console, a Hand Piece, and a Cable. It also describes the physical mechanism of action involving saline and acoustic waves generated by the Hand Piece. While software is mentioned in the performance studies, the device is not solely software.
Based on the provided information, the Soliton Resonic™ Rapid Acoustic Pulse device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Soliton Resonic™ device generates acoustic waves that are applied externally to the skin for tattoo removal and cellulite improvement. It does not analyze samples taken from the body.
- Intended Use: The intended uses are therapeutic/cosmetic procedures performed on the skin surface, not diagnostic tests on biological samples.
Therefore, the Soliton Resonic™ Rapid Acoustic Pulse device falls under the category of a therapeutic or cosmetic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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 shortterm improvement in the appearance of cellulite.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (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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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)
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.
5304 Ashbrook Drive
Houston, TX 77081 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leslie Honda
VP, Regulatory Affairs and Quality Systems
Tel: 206.375.8586 |
| Date Prepared: | March 31, 2021 |
| Trade Name: | Soliton Resonic™ Rapid Acoustic Pulse Device |
| Common Name: | Dermatology Laser System |
| Classification: | Class II
Laser surgical instrument for use in general and plastic surgery and in
dermatology (21 CFR 878.4810)
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
4
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.