(Hli) Carbon Dioxide Systems W/Infraguide CO2

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

510(k) Number

K885181 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• 4000/4900/6000/8000/8900 Yag, & 1700 Yag/CO2 Laser

  Class II

  FDA 510(k) K881619 Active Cleared 8 Jul 1988

• Hercules 5000 and Hercules 5040 Nd:yag Laser Syste

  Class II

  FDA 510(k) K913564 Active Cleared 16 Sep 1991

• Carbon Dioxide Laser Systems W/Arthoguide CO2 Del.

  Class II

  FDA 510(k) K910496 Active Cleared 6 May 1991

• Heraeus Lasersonics CO2 Waveguide Delivery System

  Class II

  FDA 510(k) K900751 Active Cleared 3 May 1990

• Hercules Model 5060 and 5100 Nd:yag Laser Systems

  Class II

  FDA 510(k) K923896 Active Cleared 25 Nov 1992

• Illumina Model 25, 40 and 55 CO2 Laser Systems

  Class II

  FDA 510(k) K895263 Active Cleared 20 Oct 1989

See all devices from Heraeus Lasersonics, Inc. →

• What is the primary function of the HLI Carbon Dioxide Systems with Infraguide CO2?

  This device is a powered laser surgical instrument engineered to deliver carbon dioxide laser energy. It is specifically intended for use by clinicians performing procedures within the fields of general and plastic surgery.

• What is the regulatory status of this laser system?

  The HLI Carbon Dioxide Systems with Infraguide CO2 has received FDA 510(k) clearance under submission number K885181. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

• Who is the manufacturer of this surgical laser?

  The device is manufactured by Heraeus Lasersonics, Inc., located in Santa Clara, California. They are the applicant responsible for the device's 510(k) clearance.