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Bio-Med USA, Inc.

Also registered as Bio-Med USA

United StatesFDA applicant, unverified

Devices
11

What Bio-Med USA, Inc. makes

Bio-Med USA, Inc. manufactures medical lasers, including the IRIS Pi Q switched Nd:YAG laser, Cellene CO₂ laser system, and Dental 5 Multi Diode laser, as well as insulin syringes (1cc, 0.5cc, 0.3cc) and BOTOX syringes. The company also produces the Picore, MX-7000 Microxel, ATOVEN, LUCID LY, and WANDY Dispersvie Electrode for medical and dental applications.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

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  • IRIS Pi Q switched Nd YAG laser Ref K221789

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

  • Unitox Botox Syringe Ref K123710

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

  • Picore Ref K212082

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

  • Mx-7000 Microxel Ref K111831

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

  • Atoven Ref K133774

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

  • Cellene CO2 Laser System Ref K182270

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

  • Bt-400 Ref K142332

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

  • Dental 5 Multi Diode laser Ref K163638

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

  • Bio-Med Soft Insulin Syringe: Models 1cc, 0.5cc, 0.3cc Ref K081547

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

  • Lucid Ly Ref K140837

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

  • Wandy Dispersvie Electrode Ref K121268

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

Rows 1-11 of 11

Frequently asked questions

How many devices does Bio-Med USA, Inc. have in the registry?

The registry currently lists 11 devices for Bio-Med USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bio-Med USA, Inc.'s devices?

Among its 11 most recently registered devices, Bio-Med USA, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Bio-Med USA, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Bio-Med USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Bio-Med USA, Inc. in the registry?

The most recently registered devices listed for Bio-Med USA, Inc. include IRIS Pi Q switched Nd YAG laser, UNITOX BOTOX SYRINGE, Picore and MX-7000 MICROXEL.

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