Model 4900 Nd:YAG Laser for Endometrial Ablation
by Cooper Lasersonics, Inc. 510(k)
Active
510(k) K880173
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880173 | Date24 Mar 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 1 Oct 2026
The Model 4900 Nd:YAG Laser for Endometrial Ablation is a Laser, Surgical, Gynecologic device, classified under the FDA’s Class II regulatory category. It employs a neodymium-doped yttrium aluminium garnet (Nd:YAG) laser to perform endometrial ablation, a procedure used to treat abnormal uterine bleeding by selectively destroying the endometrial lining. This device is designed for minimally invasive gynecological interventions, leveraging laser energy to achieve precise tissue effects without direct mechanical contact. Its application is governed by the FDA’s 21 CFR 884.4550 regulation, ensuring compliance with surgical laser standards.
The Model 4900 is supplied as a reusable medical device, intended for use in clinical settings such as outpatient surgical centers or hospital operating rooms. It requires proper sterilization and maintenance per manufacturer guidelines to ensure safety and performance. The device is not MRI-safe and must be used in environments where electromagnetic interference is controlled. Registration numbers 3009736547, 3004167969, 2938071, and 9611102 reflect its compliance with FDA reporting requirements, and it holds a Traditional 510(k) clearance under the Obstetrics/Gynecology advisory committee. Storage and handling must adhere to sterile procedures to prevent contamination.
Other devices from Cooper Lasersonics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Model 4900 Nd:YAG Laser used for?
The Model 4900 Nd:YAG Laser is designed specifically for endometrial ablation, a procedure that targets and destroys the endometrial lining to treat abnormal uterine bleeding. By using neodymium-doped yttrium aluminium garnet (Nd:YAG) laser energy, it achieves controlled tissue effects without direct mechanical contact, making it suitable for minimally invasive gynecological interventions.
Is the Model 4900 Nd:YAG Laser reusable or single-use?
The Model 4900 Nd:YAG Laser is a reusable medical device. It is intended for use in clinical environments such as outpatient surgical centers or hospital operating rooms, where it can be sterilized and maintained per manufacturer guidelines to ensure safety and optimal performance.
What sterilization and maintenance procedures are required for the Model 4900?
The device must undergo proper sterilization and maintenance following the manufacturer’s established protocols to preserve its functionality and safety. Since it is reusable, adherence to sterile procedures is critical to prevent contamination and ensure reliable performance during endometrial ablation procedures.
Can the Model 4900 Nd:YAG Laser be used in an MRI environment?
No, the Model 4900 Nd:YAG Laser is not MRI-safe. It must be used in environments where electromagnetic interference is carefully controlled to avoid potential risks or interference with diagnostic imaging equipment.
What regulatory compliance does the Model 4900 Nd:YAG Laser hold?
The Model 4900 Nd:YAG Laser holds a Traditional 510(k) clearance under the FDA’s Obstetrics/Gynecology advisory committee. It is classified under FDA’s Class II regulatory category and adheres to the standards outlined in 21 CFR 884.4550, ensuring compliance with surgical laser requirements.