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FDA 510(k)

POWERLASER

K-Number: K070516 · 2007-07-02

ApplicantPowermedic Aps
Decision Date2007-07-02
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

POWERLASER is the device name listed in this FDA 510(k) record. The listed applicant is Powermedic Aps. It received FDA 510(k) clearance on 2007-07-02 under 510(k) number K070516. 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 POWERLASER?

POWERLASER is a medical device that received FDA 510(k) clearance on 2007-07-02. The listed applicant is Powermedic Aps. The 510(k) number is K070516.

When did POWERLASER receive FDA 510(k) clearance?

POWERLASER received FDA 510(k) clearance on 2007-07-02, under 510(k) number K070516.

Who is the listed applicant for POWERLASER?

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

What is the FDA product code for POWERLASER?

The FDA product code for POWERLASER 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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