Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Silk'n MODEL H5003 device

K-Number: K180279 · 2018-05-09

ApplicantHome Skinovations , Ltd.
Decision Date2018-05-09
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Silk'n MODEL H5003 device is a medical device manufactured by Home Skinovations , Ltd.. It received FDA 510(k) clearance on 2018-05-09 under approval number K180279. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Silk'n MODEL H5003 device?

Silk'n MODEL H5003 device is a medical device that received FDA 510(k) clearance on 2018-05-09. It is manufactured by Home Skinovations , Ltd.. The 510(k) number is K180279.

When was Silk'n MODEL H5003 device approved by the FDA?

Silk'n MODEL H5003 device received FDA 510(k) clearance on 2018-05-09, under approval number K180279.

What company makes Silk'n MODEL H5003 device?

Silk'n MODEL H5003 device is manufactured by Home Skinovations , Ltd..

What is the FDA product code for Silk'n MODEL H5003 device?

The FDA product code for Silk'n MODEL H5003 device is NGX.

Related Clinical Trials

NCT06291818 Self-Adhering Magnetic Device to Treat Corneal Exposure RECRUITING NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT06377007 Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION) COMPLETED NCT06969560 WeRoaM: Wearable Remote Monitoring in Heart Failure RECRUITING NCT05116176 TRAjectories and CLinical ExpeRiences of ICD Therapy Study ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 40408133 A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study. Journal of medical Internet research (2025)

Other Devices by Home Skinovations , Ltd.

K152087HeatLux Pro II K171433Silk'n Infinity K162784Silk'n HST DEN190039ToothWave™ K214078Silk’n Toothwave

Related Devices (Code: NGX)

K152420AK Body Toning DeviceAk Beauty Enterprises, LLC K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd. K152480Revitive Medic; Revitive MV; Revitive LVActegy , Ltd. K151722Slim UP ULTRAAime Medical, Inc. K172876PowerDot PD-01MSmartmissimo Technologies Pte, Ltd. K172241Tyece OTC EMS System, Model EM35Tyece , 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.

↑