LENSAR Femtosecond Laser System
FDA 510(k)Class II (US FDA 510(k))
by Lensar, Inc.
Identifiers
- 510(k) Number
- K090633 FDA 510(k)
- FDA Product Code
- OOE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LENSAR Femtosecond Laser System is an ophthalmic femtosecond laser designed for refractive cataract surgery. It performs precise laser capsulotomies, lens fragmentation, limbal relaxing incisions, and corneal incisions, enabling multiple procedures in a single session with high accuracy.
This device is intended for use in clinical settings by ophthalmic surgeons and is supplied as a reusable medical instrument. It has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device (OOE). The system is not single-use and does not require sterile packaging, though proper cleaning and maintenance protocols must be followed. No specific MRI safety information is provided in the data.
Frequently asked questions
What types of procedures can the LENSAR Laser System perform during a single refractive cataract surgery session?
The LENSAR Femtosecond Laser System is designed to perform multiple precise procedures in one session, including laser capsulotomies, lens fragmentation, limbal relaxing incisions, and corneal incisions. This integration allows surgeons to streamline refractive cataract surgery by automating key steps with high accuracy.
Is the LENSAR Laser System intended for single-use or reusable applications, and what maintenance is required?
The LENSAR Laser System is a reusable medical instrument and is not single-use. While it does not require sterile packaging, it must be properly cleaned and maintained according to manufacturer guidelines to ensure optimal performance and safety in clinical settings.
How is the LENSAR Laser System regulated, and what classification does it hold under FDA guidelines?
The LENSAR Laser System has received FDA 510(k) clearance under the Traditional pathway and is classified as a Class II device (product code: OOE). This classification reflects its intended use in ophthalmic procedures, where it performs precise laser-based tasks during refractive cataract surgery.
What clinical specialties or settings is the LENSAR Laser System intended for, and who typically operates it?
The system is intended for use in clinical settings by ophthalmic surgeons specializing in refractive cataract surgery. Its design supports high-precision procedures, making it suitable for advanced ophthalmic practices where femtosecond laser technology is integrated into surgical workflows.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Femtosecond Laser System | LENSAR Inc., LENSAR Robotic Cataract Laser System for Refractive Cataract Eye Surgeons, LensAR Laser System™ from LensAR Inc. - OphthalmologyWeb, LENSAR® Laser System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090633 | Class II | Active |
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Manufacturer
- Manufacturer
- Lensar, Inc.
Sources (1)
- FDA 510(k) K090633 24 fields · synced Sep 19, 2026