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IFS Advanced Femtosecond Laser System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141852

by AMO Manufacturing USA, LLC

Identifiers

510(k) Number
K141852 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The IFS Advanced Femtosecond Laser System is a femtosecond laser device designed for ophthalmic surgical applications. It performs precise, laser-assisted lamellar resection of the cornea, enabling minimally invasive procedures such as refractive surgery and corneal transplant preparations.

This system is supplied as a reusable medical device intended for use in sterile surgical environments. It operates at 150 kHz and is regulated under FDA 510(k) clearance (K141852), classified under product code GEX for ophthalmic surgical lasers. No sterility or single-use designation is specified in the regulatory data.

Frequently asked questions

What types of ophthalmic surgeries can the IFS Advanced Femtosecond Laser System be used for, and how does it differ from traditional methods?

The IFS Advanced Femtosecond Laser System is specifically designed for laser-assisted lamellar resection of the cornea, enabling minimally invasive procedures like refractive surgery (such as LASIK or PRK) and corneal transplant preparations. Unlike traditional mechanical methods, it uses a femtosecond laser operating at 150 kHz to create precise, blade-free cuts, reducing tissue trauma and improving surgical outcomes.

Is the IFS Advanced Femtosecond Laser System intended for single-use or reusable applications, and what are the implications for sterilization?

The IFS Advanced Femtosecond Laser System is explicitly described as a reusable medical device, meaning it is meant to be used in sterile surgical environments repeatedly. Since it is not designated as single-use, proper sterilization protocols must be followed between procedures to maintain safety and functionality, though the regulatory data does not specify sterilization methods.

What regulatory pathway was followed for FDA clearance of this device, and how does that affect its use in clinical settings?

The IFS Advanced Femtosecond Laser System received FDA clearance through a 510(k) submission (K141852), classified under product code GEX for ophthalmic surgical lasers. This pathway demonstrates that the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed for its intended ophthalmic surgical applications without additional clinical trials.

How does the operating frequency of the laser (150 kHz) impact its performance in corneal procedures?

The IFS Advanced Femtosecond Laser System operates at 150 kHz, which allows for rapid, high-precision tissue ablation. This frequency enables faster lamellar cuts while maintaining micrometer-level accuracy, reducing surgical time and improving consistency in procedures like refractive surgery and corneal transplants compared to slower or less precise methods.

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: MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC IFS FEMTOSECOND ..., PDF iFS Advanced Femtosecond Laser - assets.contentstack.io, PDF iFSTM Advanced Femtosecond Laser System, iFS™ Advanced Femtosecond Laser | J&J Vision Professional

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
AMO Manufacturing USA, LLC

Sources (1)

  • FDA 510(k) K141852 24 fields · synced Sep 18, 2026