Lasag Microruptor 2 Nd:Yag Ophthalmic Laser System
510(k) K885164
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK885164 | Date10 Jan 1989 | 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- Withdrawn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
- Full name
- Lasag Microruptor 2 Nd:yag Ophth. Laser System
- 510(k) Number
- FDA Product Code
- HQF
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4390
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Lasag Microruptor 2 Nd:Yag Ophthalmic Laser System is a Class II ophthalmic laser device designed for precise laser treatments in eye surgery. It utilizes neodymium-doped yttrium aluminum garnet (Nd:YAG) laser technology to deliver controlled energy for procedures such as posterior capsulotomy, iridotomy, and other intraocular applications. This system is engineered to provide accurate and repeatable laser emissions for microsurgical interventions within the eye.
The device is supplied as a reusable medical instrument intended for use in clinical settings such as ophthalmology clinics and surgical centers. It requires proper maintenance and sterilization protocols to ensure safety and functionality. The system is regulated under FDA 510(k) clearance with a traditional review process, classified under the product code HQF and regulation number 886.4390. No specific sterility or MRI safety information is provided in the data, but adherence to manufacturer guidelines is essential for optimal performance and patient safety.