Cleared Traditional

Soliton Acoustic Wave Device (K190542) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K190542 · Soliton, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
81d
Days
Class 2
Risk

K190542 is an FDA 510(k) clearance for the Soliton Acoustic Wave Device. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Soliton, Inc. (Houston, US). The FDA issued a Cleared decision on May 24, 2019 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Soliton, Inc. devices

Submission Details

510(k) Number K190542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date May 24, 2019
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice M. Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03125824 Completed Interventional Industry-sponsored

Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial Protocol

Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial

20
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Tattooing
Study design Single group
Eligibility All sexes · 22 Years+
Principal investigator Christopher Cappelli, MD
Sponsor Soliton (industry)
Started 2017-02-13 → Primary completion 2018-05-23 → Completed 2018-09-25
Primary outcome
Tattoo clearance
Secondary outcome
Incidence of Treatment Emergent Adverse Events for Safety Reporting
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 533
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K190542.
Phototherapy System
K190938 · Shanghai Apolo Medical Technology Co., Ltd. · Jun 2019
Q-Switched Nd: YAG Laser System
K190936 · Shanghai Apolo Medical Technology Co., Ltd. · Jun 2019
CLARITY II Laser System
K183566 · Lutronic Corporation · Jun 2019
TRIO Handpiece
K183199 · Omniguide, Inc. · May 2019
V-Laser
K183156 · Wontech Co., Ltd. · Apr 2019
Diode Laser Treatment System
K182924 · Weifang KM Electronics Co., Ltd. · Apr 2019