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FDA 510(k)

FREEDOM ND: YAG LASER SYSTEM

K-Number: K113843 · 2012-09-27

ApplicantLutronic Corporation
Decision Date2012-09-27
Product CodePDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FREEDOM ND: YAG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2012-09-27 under 510(k) number K113843. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREEDOM ND: YAG LASER SYSTEM?

FREEDOM ND: YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-27. The listed applicant is Lutronic Corporation. The 510(k) number is K113843.

When did FREEDOM ND: YAG LASER SYSTEM receive FDA 510(k) clearance?

FREEDOM ND: YAG LASER SYSTEM received FDA 510(k) clearance on 2012-09-27, under 510(k) number K113843.

Who is the listed applicant for FREEDOM ND: YAG LASER SYSTEM?

The FDA 510(k) record lists Lutronic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FREEDOM ND: YAG LASER SYSTEM?

The FDA product code for FREEDOM ND: YAG LASER SYSTEM is PDZ.

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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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