Sharplan Nd:yag Disposable Fiber Delivery System

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

510(k) Number

K900153 ↗

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 ND:YAG Disposable Fiber Delivery System used for?

  This device serves as a conduit to transmit laser energy from the ND:YAG laser source to target tissue during surgical procedures. It is designed specifically for use with compatible ND:YAG laser systems in clinical or surgical settings.

• Is the Sharplan ND:YAG fiber delivery system reusable or single-use?

  The device is supplied as a single-use, sterile unit intended for one-time application only. After use, it should be discarded according to medical waste disposal protocols to ensure safety and prevent cross-contamination.

• How should the Sharplan ND:YAG Disposable Fiber Delivery System be stored?

  The system should be stored in a dry environment to maintain its integrity and functionality. Proper storage conditions help preserve the sterile packaging and ensure the device performs as intended when used in surgical procedures.

• What regulatory authorization does the Sharplan ND:YAG Disposable Fiber Delivery System have?

  The device has received FDA 510(k) clearance with the K number K900153. It was determined to be substantially equivalent to predicate devices in the General and Plastic Surgery advisory committee category, with a traditional clearance type.