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Data / Medical devices / United States / Preferred Depot

Preferred Depot: FDA-registered device maker in Irvine, CA, United States, 16 510(k) clearances

Preferred Depot is registered with the FDA (registration 3013917867) in Irvine, CA, United States. It lists 15 device types. The FDA files 16 510(k) clearances under its listings, the newest dated July 2, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Preferred Depot
FDA registration number
3013917867
Address
39 Parker, Irvine, CA, United States, 92618
Owner or operator
Preferred Depot (10060025)
Roles
Contract manufacturer, Remanufacturer, Repackager or relabeler
First device listed
March 21, 2019
Registered through
2027
Brand names listed
BRH Medical Ltd., Contour, EndyGel, EndyMed Pro, Endymed, FSR Fractional Skin Resurfacing Applicator, Glow Pure, I-Tech Industries and more

Devices it lists

DeviceProduct codeClassRoleSource
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Focused Ultrasound For Tissue Heat Or Mechanical Cellular DisruptionOHV2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Interferential Current TherapyLIH2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Massager, Vacuum, Light Induced HeatingNUV2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced HeatPBX2Repackager or relabeleraccessdata.fda.gov
Media, ElectroconductiveGYB2Repackager or relabeleraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufactureraccessdata.fda.gov
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle ReductionPAY2Repackager or relabeleraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Skin Resurfacing Rf ApplicatorOUH2Repackager or relabeleraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Ultrasonic Diathermy For Use In Applying Therapeutic Deep HeatIMI2Remanufacturer, Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 2, 2025K251746Pure ImpactNGXSubstantially EquivalentSofwave Medical, Ltd.accessdata.fda.gov
April 18, 2025K250146SofWave SystemNGXSubstantially EquivalentSofwave Medical, Ltd.accessdata.fda.gov
May 30, 2024K240687SofWave SystemOHVSubstantially EquivalentSofwave Medical, Ltd.accessdata.fda.gov
October 7, 2022K222369PURE LaserGEXSubstantially EquivalentEndymed Medical, Ltd.accessdata.fda.gov
November 15, 2021K211483SofWave SystemOHVSubstantially EquivalentSofwave Medical, Ltd.accessdata.fda.gov
June 22, 2021K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)NUVSubstantially EquivalentI-Tech Industries Srlaccessdata.fda.gov
September 9, 2019K191421Sofacia SystemOHVSubstantially EquivalentSofwave Medical, Ltd.accessdata.fda.gov
January 11, 2019K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)NUVSubstantially EquivalentI-Tech Industries Srlaccessdata.fda.gov
August 25, 2017K160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)IMISubstantially EquivalentBrh Medical , Ltd.accessdata.fda.gov
February 7, 2017K161715EndyGelGYBSubstantially EquivalentEndymed Medical, Ltd.accessdata.fda.gov
August 1, 2016K161199EndyMed Contour HandpiecePBXSubstantially EquivalentEndymed Medical, Ltd.accessdata.fda.gov
December 18, 2015DEN150005Newa Skin Therapy SystemPAYUnknownEndymed Medical, Ltd.accessdata.fda.gov
August 16, 2013K130793NEWA SKIN THERAPY SYSTEMGEISubstantially EquivalentEndymion Medical, Ltd.accessdata.fda.gov
May 8, 2012K120513GLOW BY ENDYMEDOUHSubstantially EquivalentEndymed Medical, Ltd.accessdata.fda.gov
February 17, 2011K101510FRACTIONAL SKIN RESURFACING (FSR) APPLICATOROUHSubstantially EquivalentEndymed Medical, Ltd.accessdata.fda.gov
July 24, 2009K083461IMAGINE TC SKIN THERAPY SYSTEMGEISubstantially EquivalentEndymion Medical, Ltd.accessdata.fda.gov

Compare with other makers

Updated July 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.