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FDA 510(k)

Sofacia System

K-Number: K191421 · 2019-09-09

ApplicantSofwave Medical, Ltd.
Decision Date2019-09-09
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sofacia System is the device name listed in this FDA 510(k) record. The listed applicant is Sofwave Medical, Ltd.. It received FDA 510(k) clearance on 2019-09-09 under 510(k) number K191421. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sofacia System?

Sofacia System is a medical device that received FDA 510(k) clearance on 2019-09-09. The listed applicant is Sofwave Medical, Ltd.. The 510(k) number is K191421.

When did Sofacia System receive FDA 510(k) clearance?

Sofacia System received FDA 510(k) clearance on 2019-09-09, under 510(k) number K191421.

Who is the listed applicant for Sofacia System?

The FDA 510(k) record lists Sofwave Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sofacia System?

The FDA product code for Sofacia System is OHV.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07685821In Vivo Study to Evaluate Tissue Remodeling Via Fibroblast Stimulation Following a Single SofWave TreatmentACTIVE_NOT_RECRUITINGNCT07685834Evaluation of Facial and Neck Skin Laxity With SofWave Treatment in Adults Initiating Tirzepatide for Weight LossACTIVE_NOT_RECRUITINGNCT07723664Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck RejuvenationNOT_YET_RECRUITING

Other records listing Sofwave Medical, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251746Pure ImpactK250146SofWave SystemK241685SofWave SystemK240687SofWave SystemK233104SofWave SystemK232455SofWave System

View all 12 devices →

Related Devices (Code: OHV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260618Ulthera® SystemUlthera, Inc.K250418Ulthera System (UC-1 Control Unit PRIME Model 2.1)Ulthera, Inc.K243035Ulthera® SystemUlthera, Inc.K240687SofWave SystemSofwave Medical, Ltd.K233996Ulthera System (UC-1 Control Unit PRIME)Ulthera, Inc.K233104SofWave SystemSofwave Medical, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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