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Ellman Intl., Inc.

Also registered as Ellman Intl. Mfg., Inc.

United StatesFDA applicant, unverified

Devices
23

What Ellman Intl., Inc. makes

Ellman Intl., Inc. manufactures electrosurgical and radiofrequency devices for medical and aesthetic procedures, including the Surgitron series of radiosurgical units, the Surgi-Max system, and the Dento-Surge dental device. The company also produces non-ablative wrinkle treatment handpieces such as the Pelleve and non-ablative wrinkle treatment handpiece, as well as accessories like the Ellman needle extender/measured dose syringe and Medifrig cooling device.

All listed devices are classified as Class II medical devices and are registered in the FDA 510(k) database. The company is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue23

Newest first, rows 1-23 of 23

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  • Surgitron Units- Electro Surg Syst Gyn Indication Ref K914329

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Dento-Surge Ref K955176

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Non-Ablative Wrinkle Treatment Handpiece Ref K102368

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Medi-Frig Ref K954703

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitron Ref K955167

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitron Model Ffpf-Emc Ref K972072

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitron 120 Iec (Also Known As Surgitron 4.0 Dual Rf Ref K013255

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' Ref K101967

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgi-Max Ref K061174

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitron Radiolase Ref K992382

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitron Ref K911461

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ellman Needle Extender/Measured Dose Syringe Ref K954718

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sugitron Model: Iec Ref K980177

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ellman International Non-Ablative Technique For Surgitron Iec Ref K082834

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bipolar Trigger-Flex Probe Ref K003126

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe Ref K102698

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitron Ref K980170

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitron Iec Ii Ref K001986

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitron Ref K990146

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitron Radiolase Ii Ref K042710

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitron Ref K955158

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitron Iec Ii Ref K001253

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitron Iec Ii Ref K001407

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-23 of 23

Frequently asked questions

How many devices does Ellman Intl., Inc. have in the registry?

The registry currently lists 23 devices for Ellman Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ellman Intl., Inc.'s devices?

Among its 23 most recently registered devices, Ellman Intl., Inc. has devices listed in FDA 510(k) (23 devices).

What risk classes do Ellman Intl., Inc.'s devices fall under?

Among its 23 most recently registered devices, the classes recorded for Ellman Intl., Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Ellman Intl., Inc. in the registry?

The most recently registered devices listed for Ellman Intl., Inc. include SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION, DENTO-SURGE, NON-ABLATIVE WRINKLE TREATMENT HANDPIECE and MEDI-FRIG.

Generated automatically from registry data and not verified by a human reviewer.