PC Laser with Smart Plug (PC Edo & Dental 200)

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

510(k) Number

K963124 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Dental 200, Dental 300, Dental 400, Models E-20, E-60, E-50

  Class II

  FDA 510(k) K991464 Active Cleared 20 Jul 1999

• Atlas-Elite, Model E-80, Corium 200, Corium 400, Model E-90, Elite, Model E-80-Ii, Elite Ultra, Model E-80-Iv

  Class II

  FDA 510(k) K990174 Active Cleared 1 Apr 1999

• Veinlase, Model E50-K8-B5, Spectrum K8, Model E50-K8-B9

  Class II

  FDA 510(k) K000158 Active Cleared 24 Aug 2000

• What is the PC Laser with Smart Plug (Dental 200) used for?

  The PC Laser with Smart Plug (Dental 200) is a powered laser surgical instrument designed for precision cutting, coagulation, or vaporization of tissue. It is intended for use in general surgery, plastic surgery, and dental procedures where controlled laser energy is required for therapeutic interventions. The device’s laser technology allows clinicians to perform minimally invasive treatments with enhanced accuracy.

• Is the PC Laser with Smart Plug (Dental 200) reusable or single-use?

  The PC Laser with Smart Plug (Dental 200) is supplied as a reusable medical instrument. It is intended for use in sterile environments, meaning it must be properly cleaned, sterilized, and maintained between procedures to ensure safety and functionality. Reusability is common for high-precision surgical tools to balance cost and performance.

• What regulatory approval does the PC Laser with Smart Plug (Dental 200) hold?

  The PC Laser with Smart Plug (Dental 200) holds FDA 510(k) clearance under the reference number K963124. This clearance indicates that the device is substantially equivalent to a predicate device and meets FDA requirements for safety and effectiveness. The device falls under the GEX product code, classified as Class II – Special Controls, and was reviewed by the FDA’s advisory committee for General and Plastic Surgery.

• How should the PC Laser with Smart Plug (Dental 200) be stored?

  While specific storage conditions are not detailed in the regulatory submission, standard medical device protocols should be followed. This includes storing the device in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring it is protected from physical damage. Proper storage helps maintain the device’s performance and longevity for reuse.

• What distinguishes the PC Laser with Smart Plug (Dental 200) from other laser devices?

  The PC Laser with Smart Plug (Dental 200) is distinguished by its Smart Plug feature, which likely enhances functionality or connectivity for surgical applications. It is specifically designed for precision in dental, plastic, and general surgery, offering controlled laser energy for cutting, coagulation, or vaporization. The device’s FDA clearance under K963124 and its classification under GEX further validate its specialized role in surgical settings.