Sharplan 2100 Sterile

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

Full name

Modified Labeling Packaging Sharplan 2100 Sterile

510(k) Number

K891088 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Sharplan Model 1050 Sealed-Off CO2 Surgical Laser

  Class II

  FDA 510(k) K890287 Active Cleared 12 Apr 1989

• Sharplan Model 1080S CO2 Surgical Laser

  Class II

  FDA 510(k) K933918 Active Cleared 25 Aug 1994

• Sharplan Model 750 Remote Control Unit (Rcu)

  Class II

  FDA 510(k) K890286 Active Cleared 5 Apr 1989

• Sharplan Nd:yag Lasers for ENT and Neck Surgery

  Class II

  FDA 510(k) K900345 Active Cleared 10 Apr 1990

• Sharplan CO2 Surg. Laser, Mo. 1039 Surgicenter 40

  Class II

  FDA 510(k) K921146 Active Cleared 8 Jun 1992

• Sharplan Nd:yag Surgical Laser, Model 3060 Sharplaser 60

  Class II

  FDA 510(k) K926543 Active Cleared 9 Mar 1994

See all devices from Sharplan Lasers, Inc. →

• What is the Sharplan 2100 Sterile used for in surgical procedures?

  The Sharplan 2100 Sterile is a powered laser surgical instrument designed for precision tissue manipulation in controlled surgical environments. It is specifically intended for general and plastic surgery applications, where it can be used for tissue ablation (removal), coagulation (sealing blood vessels), or vaporisation (evaporating tissue). The device’s laser technology allows clinicians to perform these functions with enhanced accuracy, reducing trauma to surrounding tissues.

• Is the Sharplan 2100 Sterile single-use or reusable?

  The Sharplan 2100 Sterile is supplied in sterile packaging and is intended for single-use only. This design ensures clinical safety by eliminating the risk of cross-contamination between patients, which is critical in surgical settings where sterility is non-negotiable. Reuse is not recommended or supported by the manufacturer.

• How is the sterility of the Sharplan 2100 Sterile maintained?

  The device is packaged in sterile packaging, which is designed to preserve its sterility until first use. The sterile barrier prevents microbial contamination during storage and transport. Once opened, the device should be used immediately in a controlled surgical environment to maintain aseptic conditions. The manufacturer’s packaging instructions should always be followed to ensure sterility is upheld.

• What regulatory clearance does the Sharplan 2100 Sterile hold?

  The Sharplan 2100 Sterile holds FDA 510(k) clearance under the reference number K891088, granted in 1989. This clearance was determined under a Substantially Equivalent (SE) classification, meaning the device was found to be as safe and effective as a legally marketed predicate device. The device is classified under the GEX product code, which pertains to powered surgical instruments, and is subject to special controls for laser safety and performance.

• Can the Sharplan 2100 Sterile be used in MRI-compatible environments?

  No, the Sharplan 2100 Sterile is not intended for use in MRI-compatible environments. The device is designed exclusively for traditional surgical settings where standard laser safety protocols apply. MRI environments require specialized equipment that can safely operate without interfering with magnetic resonance imaging, and this device does not meet those criteria.