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FDA 510(k)

3B LASER NEEDLE

K-Number: K131797 · 2013-10-10

ApplicantLivetec GmbH
Decision Date2013-10-10
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

3B LASER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Livetec GmbH. It received FDA 510(k) clearance on 2013-10-10 under 510(k) number K131797. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3B LASER NEEDLE?

3B LASER NEEDLE is a medical device that received FDA 510(k) clearance on 2013-10-10. The listed applicant is Livetec GmbH. The 510(k) number is K131797.

When did 3B LASER NEEDLE receive FDA 510(k) clearance?

3B LASER NEEDLE received FDA 510(k) clearance on 2013-10-10, under 510(k) number K131797.

Who is the listed applicant for 3B LASER NEEDLE?

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

What is the FDA product code for 3B LASER NEEDLE?

The FDA product code for 3B LASER NEEDLE is ILY.

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Official Source

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

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