Device Information
The MR Q family of devices is an ophthalmic laser system used for various eye surgeries. It includes the MR Q, MR Q SUPINE, and MR Q SLT models. These lasers can perform posterior capsulotomy, iridotomy, and selective laser trabeculoplasty in specific modes. The devices are designed to provide precision during eye surgeries, contributing to effective patient outcomes.
Indications
The MR Q and MR Q SUPINE are used for posterior capsulotomy and iridotomy, while the MR Q SLT, in YAG mode, can perform the same procedures. The MR Q SLT in SLT mode is used for selective laser trabeculoplasty.
Intended Use
The MR Q series devices are intended for use by trained ophthalmic surgeons.
Availability
Prescription use only (Part 21 CFR 801 Subpart D).
Regulatory Information
- Regulation Number: 21 CFR 886.4390
- Regulatory Class: Class II
- Product Code: HQF
- 510(k) Number: K232417
The device must comply with the FDA’s general controls, including quality system regulations and medical device reporting requirements. Additional regulations, like design control (21 CFR 820.30), are also applicable.
Manufacturer Information
- Name: Meridian AG
- Address: Bierigutstrasse 7, Thun, CH CH-3608
- Contact Person: Kevin Walls, Regulatory Insight, Inc., Littleton, Colorado, USA
Implications
The MR Q laser system provides a solution for ophthalmic surgeries.
References
- MR Q; MR Q SUPINE; MR Q SLT. K232417. Meridian AG: FDA Summary Link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K232417
- Manufacturer’s website: https://www.meridian.ch/
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