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Premier Laser Systems, Inc.

United StatesFDA applicant, unverified

Devices
14

What Premier Laser Systems, Inc. makes

Premier Laser Systems, Inc. manufactures surgical laser systems, including diode, argon, and Nd:YAG laser platforms designed for medical procedures. Their product line covers systems like the Aurora Surgical Diode Laser, Pegasus Nd:YAG Laser, and Argo, as well as specialized variants such as the Centauri and BluLaze. Accessories for these systems are also part of their offerings, supporting applications in dermatology, ophthalmology, and general surgery.

The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Their products are registered in the U.S. market, adhering to FDA requirements for laser-based medical instruments. The company is headquartered in the United States.

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

Catalogue14

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  • Aurora Surgical Diode Laser System W/Accessories Ref K954316

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

  • Pegasus Nd:yag Laser System Ref K980559

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

  • Arago Ref K971118

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

  • Aurora Diode Laser System Ref K974586

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

  • Blulaze Ref K992620

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

  • Argon Curing Laser Ref K961682

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

  • Aurora Sl Ref K993285

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

  • Centauri Ref K983211

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

  • Aurora Hl Ref K992374

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

  • Centauri Ref K932683

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

  • Pegasus Ref K925178

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

  • Aurora Ref K981379

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

  • Centauri Ref K933841

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

  • Dermium Ref K980561

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

Rows 1-14 of 14

Frequently asked questions

How many devices does Premier Laser Systems, Inc. have in the registry?

The registry currently lists 14 devices for Premier Laser Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Premier Laser Systems, Inc.'s devices?

Among its 14 most recently registered devices, Premier Laser Systems, Inc. has devices listed in FDA 510(k) (14 devices).

What risk classes do Premier Laser Systems, Inc.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for Premier Laser Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Premier Laser Systems, Inc. in the registry?

The most recently registered devices listed for Premier Laser Systems, Inc. include AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES, PEGASUS ND:YAG LASER SYSTEM, ARAGO and AURORA DIODE LASER SYSTEM.

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