Yn CO2 Laser System 30W
by Cryomedics, Inc. 510(k)
Active
510(k) K844431
Overview
The YN CO₂ Laser System 30W is a Surgical Laser, Gynecologic device, classified under FDA product code HHR. It is a carbon dioxide (CO₂) laser system designed for precise surgical applications in obstetrics and gynecology, utilizing laser energy for tissue ablation, coagulation, or vaporization. Its primary function aligns with controlled surgical procedures where laser precision is required, such as in gynecological surgeries or related medical interventions.
This device is supplied as a reusable medical instrument, intended for use in sterile operating environments. The system operates at a power output of 30 watts and is regulated under FDA 510(k) clearance (K844431), with a decision date of February 25, 1985. It falls under Class II medical devices, adhering to regulatory standards for surgical lasers in obstetrics and gynecology. No additional sterility or single-use specifications are noted in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844431 | Date25 Feb 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HHR
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4550
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Cryomedics, Inc.
Questions
What types of surgical procedures is the YN CO₂ Laser System 30W primarily used for in obstetrics and gynecology?
The YN CO₂ Laser System 30W is designed for precise surgical applications in obstetrics and gynecology, where laser energy is used for tissue ablation, coagulation, or vaporization. Its primary function aligns with controlled procedures requiring laser precision, such as gynecological surgeries or related interventions. The system’s 30-watt output enables targeted tissue modification, making it suitable for delicate or specialized cases where traditional tools may be less effective.
Is the YN CO₂ Laser System 30W intended for single-use or reusable applications, and how should it be maintained?
The YN CO₂ Laser System 30W is explicitly supplied as a reusable medical instrument, meaning it is intended for use in sterile operating environments after proper cleaning and sterilization between procedures. Since no single-use specifications are noted, it must be maintained according to standard protocols for reusable surgical lasers, including cleaning, disinfection, and sterilization to ensure safety and functionality for repeated use.
What regulatory pathway was followed for FDA clearance of the YN CO₂ Laser System 30W, and what does that mean for its use?
The YN CO₂ Laser System 30W received FDA clearance through a Traditional 510(k) pathway (K844431), with a decision date of February 25, 1985. This means the device was determined to be substantially equivalent to a legally marketed predicate device, meeting FDA standards for Class II surgical lasers in obstetrics and gynecology. Clinicians may rely on this clearance as evidence of its compliance with regulatory requirements for precision laser applications in those specialties.
How is the YN CO₂ Laser System 30W categorized by the FDA, and what does that imply for its clinical application?
The YN CO₂ Laser System 30W is classified as a Class II medical device by the FDA, falling under product code HHR for surgical lasers in gynecology. This classification indicates it undergoes special controls to ensure safety and effectiveness, including performance standards and post-market surveillance. Clinicians can expect it to be subject to additional regulatory oversight beyond general medical devices, ensuring its precision and reliability in controlled surgical environments.