Illumina Model 25, 40 and 55 CO2 Laser Systems

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

510(k) Number

K895263 ↗

FDA Product Code

GEX

Models / Variants

25

40

55 CO2 Laser Systems

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

• Models 4000, 4900, 6000, 8000, 8900, Luxus 60, 100 & 1700

  Class II

  FDA 510(k) K902061 Active Cleared 10 Jul 1990

See all devices from Heraeus Lasersonics, Inc. →

• Are the Illumina CO₂ Laser Systems designed for single-use or reusable in the operating room?

  The Illumina Model 25, 40, and 55 CO₂ Laser Systems are reusable medical devices, intended for use in controlled clinical environments like surgical suites. Since they are not labeled as single-use, they must be properly cleaned, maintained, and sterilized between procedures to ensure safety and performance. Always follow manufacturer guidelines for reprocessing to comply with clinical standards.

• What types of surgical procedures are these CO₂ laser systems typically used for?

  These systems are powered laser surgical instruments designed for general and plastic surgery applications, where precise tissue ablation, coagulation, and vaporization are required. The FDA’s advisory committee classification under GEX (General/Plastic Surgery) reflects their intended use in controlled surgical settings, though the exact clinical applications would depend on surgeon preference and procedural needs.

• How do the different model numbers (25, 40, 55) differ from one another?

  The Illumina CO₂ Laser Systems come in three models—25, 40, and 55—though the regulatory data does not specify exact performance differences (e.g., power output, wavelength, or beam size). The numerical distinctions likely refer to output settings, wattage ranges, or handpiece configurations, which may influence surgical precision or tissue interaction. For precise specifications, consult the manufacturer’s technical documentation or user manual.

• Do these laser systems require any special storage conditions, and are they compatible with MRI environments?

  The regulatory data does not provide details on storage requirements for the Illumina CO₂ Laser Systems, so standard operating room conditions (clean, dry, protected from physical damage) should suffice. Regarding MRI safety, there is no explicit information in the provided data, meaning compatibility with MRI environments is not confirmed or addressed. Always verify MRI safety with the manufacturer before use in such settings.

• How was the FDA clearance for these laser systems determined, and what does the ‘SESE’ decision mean?

  The Illumina CO₂ Laser Systems received FDA 510(k) clearance (K895263) under the Substantially Equivalent (SESE) decision, meaning the FDA determined they are substantially equivalent to a legally marketed device already on the market. This classification was reviewed by the Surgical Devices (SU) Advisory Committee in 1989, with the decision based on comparisons to a predicate device rather than novel clinical breakthroughs. The ‘SESE’ label does not imply superiority but rather that the device meets existing safety and effectiveness standards.