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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 a medical device manufactured by Sie Ag,Surgical Instrument Engineering. It received FDA 510(k) clearance on 2022-04-21 under approval 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. It is manufactured by Sie Ag,Surgical Instrument Engineering. The 510(k) number is K213559.

When was FEMTO LDV Z8 Femtosecond Surgical Laser approved by the FDA?

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

What company makes FEMTO LDV Z8 Femtosecond Surgical Laser?

FEMTO LDV Z8 Femtosecond Surgical Laser is manufactured by Sie Ag,Surgical Instrument Engineering.

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 Clinical Trials

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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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