Modified Labeling & Packaging of Sharplan 2100

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

510(k) Number

K890040 ↗

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 laser system used for?

  The Sharplan 2100 is a powered laser surgical instrument used for various medical procedures. This specific version represents a modification to the existing labeling and packaging of the device.

• How is the Modified Labeling & Packaging of Sharplan 2100 supplied?

  The device is supplied with modified labeling and packaging materials. It is a Class II device with special controls, as indicated by its GEX product code.

• What is the regulatory status of this device?

  The Modified Labeling & Packaging of Sharplan 2100 received FDA 510(k) clearance on February 14, 1989, with K number K890040. It was determined to be substantially equivalent to existing devices.

• Is this device single-use or reusable?

  The device information does not specify whether it is single-use or reusable. The modification relates only to labeling and packaging, not to the device's usage characteristics.