Prodigy Nd:YAG Surgical Laser System
510(k) K914679
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK914679 | Date7 Apr 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Prodigy Nd:YAG Surgical Laser System is a laser surgical device designed for precise tissue ablation, coagulation, and vaporisation in surgical procedures. It operates using neodymium-doped yttrium aluminium garnet (Nd:YAG) laser technology, delivering high-energy laser pulses for controlled tissue interaction. This system is classified under General & Plastic Surgery applications, enabling procedures such as dermatological treatments, vascular interventions, and soft tissue surgeries. Its design supports adjustable power settings to accommodate varying clinical requirements.
The system is supplied as a reusable medical device, intended for use in sterile surgical environments by trained professionals. It is regulated under FDA 510(k) clearance (K914679), classified as a Class 2 device under product code GEX, and cleared through the Traditional 510(k) pathway. No specific MRI safety or single-use designation is stated in the regulatory data. Storage and handling must comply with standard laser safety protocols to ensure operational integrity and patient safety.
Other devices from Xintec Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the Prodigy Nd:YAG Surgical Laser System used for?
The Prodigy Nd:YAG Surgical Laser System is designed for precise surgical procedures requiring tissue ablation, coagulation, or vaporisation. It is particularly suited for dermatological treatments, vascular interventions, and soft tissue surgeries, such as those in general and plastic surgery applications. The adjustable power settings allow clinicians to tailor the laser’s energy output to the specific clinical needs of the procedure.
Is the Prodigy Nd:YAG Surgical Laser System reusable or single-use?
The Prodigy Nd:YAG Surgical Laser System is supplied as a reusable medical device. It is intended for use in sterile surgical environments by trained professionals, requiring adherence to standard laser safety protocols for proper handling, maintenance, and reprocessing to ensure operational integrity and patient safety.
What regulatory pathway does the Prodigy Nd:YAG Surgical Laser System follow?
The Prodigy Nd:YAG Surgical Laser System is cleared under the FDA’s Traditional 510(k) pathway and classified as a Class 2 device under product code GEX. It was granted FDA 510(k) clearance (K914679) in 1992, with a determination of substantial equivalence to a predicate device. This classification ensures it meets regulatory standards for safety and effectiveness in its intended surgical applications.
How should the Prodigy Nd:YAG Surgical Laser System be stored?
The Prodigy Nd:YAG Surgical Laser System must be stored and handled in compliance with standard laser safety protocols. This includes protecting it from physical damage, environmental contaminants, and improper exposure to light or moisture. Proper storage ensures the device remains operational and maintains its precision for clinical use, reducing the risk of malfunctions during surgery.
Does the Prodigy Nd:YAG Surgical Laser System have any special considerations for MRI safety?
The regulatory data for the Prodigy Nd:YAG Surgical Laser System does not specify any particular MRI safety designation. Clinicians should follow standard laser safety guidelines and consult manufacturer instructions to ensure safe use in environments where MRI compatibility may be a concern, particularly if the system or its components are exposed to magnetic fields.