Double Puncture CO2 Laser Laparoscopy Set
by Tti Medical 510(k)
Active
510(k) K870046
Overview
This device is a Laser, Surgical, Gynecologic (FDA Product Code HHR), designed for laparoscopic gynecological procedures. It features a CO₂ laser system configured for double-puncture application, enabling precise tissue ablation or coagulation during minimally invasive surgery. The set integrates laser technology with laparoscopic instrumentation to facilitate controlled surgical interventions in obstetrics and gynecology.
The Double Puncture CO₂ Laser Laparoscopy Set is intended for single-use in sterile surgical environments, adhering to Class II regulatory standards under 21 CFR 884.4550. It is supplied as a complete set and requires compatibility with standard laparoscopic equipment. Authorized by FDA 510(k) clearance (K870046), the device was reviewed by the Obstetrics/Gynecology advisory committee in 1987. No MRI safety or reusable components are specified in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870046 | Date5 Mar 1987 | 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- Withdrawn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 Tti Medical
Questions
What types of gynecological procedures is this CO₂ laser laparoscopy set designed to assist with?
This Double Puncture CO₂ Laser Laparoscopy Set is specifically designed for laparoscopic gynecological procedures, enabling precise tissue ablation or coagulation. It is intended for controlled surgical interventions in minimally invasive settings, particularly within the field of obstetrics and gynecology, such as hysteroscopic or laparoscopic surgeries where laser precision is beneficial.
Is this device meant for single-use or can it be reused after sterilization?
The Double Puncture CO₂ Laser Laparoscopy Set is explicitly intended for single-use only in sterile surgical environments. There are no reusable components or sterilization instructions specified in the regulatory data, so reuse is not recommended or supported.
How is this laser system configured, and what makes it unique compared to standard laparoscopic tools?
This set features a double-puncture CO₂ laser system, which allows for precise tissue ablation or coagulation during minimally invasive surgery. Unlike standard laparoscopic tools, it integrates laser technology directly into the laparoscopic instrumentation, enabling controlled surgical interventions with enhanced accuracy in gynecological procedures.
What storage or handling considerations should be taken into account before use?
Since this is a single-use device, it should be stored in its original, sealed packaging until ready for use to maintain sterility. The set is not designed for long-term storage or reuse, so proper handling and immediate use after opening are recommended to ensure surgical safety and compliance with sterile field protocols.
What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?
The Double Puncture CO₂ Laser Laparoscopy Set received FDA 510(k) clearance (K870046) under the Traditional review pathway, determined to be *substantially equivalent* to a legally marketed predicate device. This means it was evaluated by the FDA’s Obstetrics/Gynecology advisory committee in 1987 and deemed compliant with Class II regulatory standards (21 CFR 884.4550) for surgical lasers in gynecology. The clearance does not imply ongoing approval but confirms its compliance at the time of submission.