Modified Model 2100 Nd:YAG Laser

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

510(k) Number

K881848 ↗

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 types of medical procedures is this Nd:YAG laser primarily used for in clinical settings?

  This Modified Model 2100 Nd:YAG Laser is designed for tissue ablation and coagulation in plastic surgery and related procedures. Its high-energy infrared laser beam allows for precise cutting and sealing of tissues, making it suitable for applications like skin resurfacing, vascular lesion treatment, and other controlled tissue modifications where laser precision is critical.

• Is this device single-use or reusable, and what maintenance or sterilization steps are required?

  The Modified Model 2100 Nd:YAG Laser is reusable, meaning it can be used multiple times with proper care. Since it is a reusable medical instrument, it must be sterilized after each use following the manufacturer’s guidelines to ensure safety and functionality. Standard laser safety protocols must also be adhered to during storage and handling.

• How was this device’s regulatory approval determined, and what does the product code GEX indicate?

  This device was cleared under the FDA 510(k) process (K881848) as substantially equivalent to a predicate device, meaning the FDA determined it posed the same risks and benefits as an existing approved laser. The product code GEX categorizes it under general plastic surgery devices, reflecting its intended use in surgical and cosmetic procedures requiring Nd:YAG laser technology.

• What safety considerations should be taken into account when storing or handling this laser?

  Since this is a laser device, storage and handling must strictly follow laser safety protocols to prevent accidental exposure or damage. The manufacturer’s guidelines should be consulted for specific instructions, but generally, this includes proper containment, labeling, and ensuring the device is powered off and secured when not in use to avoid unintended activation or hazards.