Lpi Mulilase Yag/532 Surgical Laser System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K904354 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Lpi ML210 Holmium Surgical Laser, Modification

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  FDA 510(k) K914827 Active Cleared 27 Mar 1992

• Lpi ML210 Holmium Surgical Laser

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  FDA 510(k) K924537 Active Cleared 7 Apr 1993

• L.P.I. Laser Delivery System

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  FDA 510(k) K882738 Active Cleared 30 Aug 1988

• Laser Photonics Ml-210 Holmium:yag Medi Lase Syst

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  FDA 510(k) K910233 Active Cleared 12 Apr 1991

• Lpi Yag Model 1003 Surgical Laser System

  Class II

  FDA 510(k) K900837 Active Cleared 12 Jul 1990

• Lpi Yag Model 1003 Surgical Laser Syst/Modified

  Class II

  FDA 510(k) K904841 Active Cleared 19 Apr 1991

See all devices from Laser Photonics, Inc. →

• What is the LPI MULILASE YAG/532 Surgical Laser System used for?

  The LPI MULILASE YAG/532 Surgical Laser System is designed for use in general and plastic surgery procedures, utilizing YAG and 532 nm wavelengths to perform tissue ablation and coagulation during surgical interventions.

• Is the LPI MULILASE YAG/532 Surgical Laser System reusable or single-use?

  The system is supplied as a reusable surgical laser system intended for use in clinical settings, meaning it is designed for multiple uses after appropriate cleaning and maintenance between procedures.

• What regulatory authorization does the LPI MULILASE YAG/532 Surgical Laser System have?

  The device has received FDA 510(k) clearance under product code GEX and is authorized for marketing in the United States, indicating it was found substantially equivalent to a legally marketed predicate device.