Accessories for Sys. 400 CO2 Surg. Laser

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

510(k) Number

K791895 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Ocuplot D

  Class II

  FDA 510(k) K822415 Active Cleared 7 Sep 1982

• Model 900K Photocoagulator

  Class II

  FDA 510(k) K801336 Active Cleared 28 Jul 1980

• Dioptron III Autorefractor

  Class I

  FDA 510(k) K801906 Active Cleared 27 Aug 1980

• Coherent Fundusl Retinal Camera

  Class II

  FDA 510(k) K822908 Active Cleared 5 Jan 1983

• Coherent Holmium:yag Surgical Laser

  Class II

  FDA 510(k) K902990 Active Cleared 2 Oct 1990

• Neodymium: Yag Ophthalmic Laser System 9900

  Class III

  FDA PMA P830054 Active Approved 2 Jul 1984

• What is the purpose of these accessories and how do they work with the Sys. 400 CO₂ Surgical Laser?

  The accessories are intended to be integrated with the Sys. 400 CO₂ Surgical Laser, which is a powered laser used to cut, destroy, or remove tissue with carbon‑dioxide light energy. By attaching to the laser system, the accessories enable the instrument to perform its surgical functions in general and plastic surgery, as indicated by the advisory committee description. This relationship is inferred from the device description that links the accessories directly to the laser’s tissue‑interaction capabilities.

• Are the accessories supplied as sterile, and are they single‑use or reusable?

  The regulatory data does not list any sterility or single‑use specifications for the accessories, and it explicitly states they are supplied as reusable components. Because no sterility claim is provided, users should assume the items are not pre‑sterilized and must be sterilized according to their own institutional protocols before clinical use.

• What sizes or models are available for these accessories?

  The data set does not include any information about multiple sizes, models, or variations of the accessories. Since only a single device name – ACCESSORIES FOR SYS. 400 CO2 SURG. LASER – is provided, we must conclude that the filing does not differentiate among sizes or models; the accessories are offered as a single, uniform set compatible with the Sys. 400 system.

• How are the accessories packaged and what storage conditions are recommended?

  The filing contains no details on packaging type or storage requirements for the accessories. In the absence of such specifications, users should follow standard storage practices for reusable surgical components, such as keeping them in a clean, dry environment and protecting them from damage until they are sterilized and ready for use.