Models 4000, 4900, 6000, 8000, 8900, Luxus 6&100/1700 - 8900

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

510(k) Number

K904444 ↗

FDA Product Code

GEX

Models / Variants

4000

4900

6000

8000

8900

Luxus 6

100

1700

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. →

• Are these laser surgical instruments designed for single-use or can they be reused in a clinical setting?

  These instruments are reusable medical devices, meaning they are intended to be cleaned, sterilized, and reused multiple times in clinical settings where sterile conditions are maintained. Since they are classified as reusable, proper maintenance and sterilization protocols must be followed as outlined in the manufacturer’s instructions to ensure safety and performance.

• What types of surgical procedures are these laser devices primarily used for?

  These devices are powered laser surgical instruments designed for use in general and plastic surgery procedures. They utilize Nd:YAG and CO₂ laser technologies to perform precise tissue ablation, coagulation, or vaporization, making them suitable for procedures requiring controlled energy delivery in surgical environments.

• How do I determine which model is best suited for my specific surgical needs?

  Each model (e.g., 4000, 6000, Luxus 6&100/1700) corresponds to specific laser parameters and configurations, including wavelength, power output, and beam characteristics. The manufacturer’s documentation provides detailed specifications for each model, allowing you to select the one that aligns with your intended surgical application—whether for tissue ablation, coagulation, or vaporization in general or plastic surgery.

• What regulatory pathway was followed for FDA clearance of these devices?

  These devices received FDA 510(k) clearance under the Traditional 510(k) review pathway, meaning they were determined to be substantially equivalent to a legally marketed predicate device. The clearance was granted under the General, Plastic Surgery advisory committee (SU) and assigned the product code GEX. The submission was filed in 1990 and received a decision in December of the same year.