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FEMTO LDV Z8 Surgical Laser

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K150323

by SIE AG, Surgical Instrument Engineering

Identifiers

510(k) Number
K150323 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 FEMTO LDV Z8 Surgical Laser is an Ophthalmic Femtosecond Laser, designed for precise, non-contact corneal and cataract surgery. It employs ultrafast laser pulses to perform keratotomy, lens fragmentation, and capsulotomy with high accuracy, reducing reliance on mechanical tools in procedures like LASIK, SMILE, and phacoemulsification.

This device is intended for use in sterile ophthalmic operating rooms and is supplied as a reusable medical instrument. It operates within FDA and MDR regulatory frameworks, with a classification as a Class II device under the OpenFDA system. The laser system requires proper calibration, maintenance, and adherence to manufacturer guidelines to ensure safe and effective performance in clinical settings.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
SIE AG, Surgical Instrument Engineering
FDA Applicant
Sie Ag,Surgical Instrument Engineering

Sources (2)

  • FDA 510(k) K150323 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026