FDA 510(k)

FEMTO LDV Z8 Femtosecond Surgical Laser

K-Nummer: K213559 · 2022-04-21

AntragstellerSie Ag,Surgical Instrument Engineering

Entscheidungsdatum2022-04-21

ProduktcodeOOE

BeratungsausschussOP

EntscheidungSubstantially Equivalent

Produktübersicht

FEMTO LDV Z8 Femtosecond Surgical Laser is the device name listed in this FDA 510(k) record. The listed applicant is Sie Ag,Surgical Instrument Engineering. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K213559. The device is classified under product code OOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the FEMTO LDV Z8 Femtosecond Surgical Laser?

FEMTO LDV Z8 Femtosecond Surgical Laser is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Sie Ag,Surgical Instrument Engineering. The 510(k) number is K213559.

When did FEMTO LDV Z8 Femtosecond Surgical Laser receive FDA 510(k) clearance?

FEMTO LDV Z8 Femtosecond Surgical Laser received FDA 510(k) clearance on 2022-04-21, under 510(k) number K213559.

Who is the listed applicant for FEMTO LDV Z8 Femtosecond Surgical Laser?

The FDA 510(k) record lists Sie Ag,Surgical Instrument Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEMTO LDV Z8 Femtosecond Surgical Laser?

The FDA product code for FEMTO LDV Z8 Femtosecond Surgical Laser is OOE.

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Verwandte Geräte (Code: OOE)

K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC K220259ALLY Adaptive KataraktbehandlungssystemLensar, Inc.K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC

Offizielle Quelle

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