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FDA 510(k)

FEMTO LDV Z8 Femtosecond Surgical Laser

K-Number: K213559 · 2022-04-21

ApplicantSie Ag,Surgical Instrument Engineering
Decision Date2022-04-21
Product CodeOOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: OOE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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, LLCK220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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