Optica 60 Nd:YAG Surgical Laser System
by Xintec Corporation 510(k)
Active
510(k) K912703
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK912703 | Date11 Oct 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Models / Variants
- 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 Optica 60 Nd:YAG Surgical Laser System is a powered laser surgical instrument designed for precise tissue ablation and coagulation. Classified under the GEX product code, it is intended for use in general and plastic surgery procedures requiring controlled laser energy delivery. This system operates using neodymium-doped yttrium aluminium garnet (Nd:YAG) laser technology, delivering high-energy pulses for surgical applications.
This device is supplied as a reusable medical instrument, requiring proper maintenance and calibration to ensure safety and efficacy. It is not intended for single-use and must be cleaned, disinfected, and stored according to manufacturer guidelines. The system is regulated under FDA 510(k) clearance (K912703) and falls under Class II – Special Controls. No specific MRI safety information is provided, and its use should adhere to standard laser safety protocols in clinical settings.
Other devices from Xintec Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the Optica 60 Nd:YAG Surgical Laser System used for?
The Optica 60 Nd:YAG Surgical Laser System is designed for precise tissue ablation and coagulation in surgical procedures. It uses neodymium-doped yttrium aluminium garnet (Nd:YAG) laser technology to deliver controlled high-energy pulses, making it suitable for general and plastic surgery applications where laser energy must be carefully managed.
Is the Optica 60 Nd:YAG Surgical Laser System reusable or single-use?
This device is a reusable medical instrument. It requires proper maintenance, cleaning, disinfection, and calibration to ensure safety and performance. Single-use is not recommended, and adherence to manufacturer guidelines for reprocessing is essential.
What regulatory clearance does the Optica 60 Nd:YAG Surgical Laser System hold?
The Optica 60 Nd:YAG Surgical Laser System holds FDA 510(k) clearance under the product code GEX, classified as substantially equivalent. It was reviewed by the Surgical Devices Subcommittee (SU) and granted clearance on October 11, 1991, under the traditional clearance process.
How should the Optica 60 Nd:YAG Surgical Laser System be stored?
The system must be stored in a clean, dry environment following manufacturer guidelines to prevent contamination or damage. Proper storage ensures the device remains functional and safe for subsequent use, particularly after cleaning and disinfection.
Are there any special considerations for MRI safety with this device?
No specific MRI safety information is provided for the Optica 60 Nd:YAG Surgical Laser System. If used in an MRI environment, standard laser safety protocols must be followed, and the device should not be exposed to MRI fields unless explicitly approved for such use.