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FDA 510(k)

PixelShine

K-Number: K161625 · 2016-09-19

ApplicantAlgomedica
Decision Date2016-09-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PixelShine is a medical device manufactured by Algomedica. It received FDA 510(k) clearance on 2016-09-19 under approval number K161625. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PixelShine?

PixelShine is a medical device that received FDA 510(k) clearance on 2016-09-19. It is manufactured by Algomedica. The 510(k) number is K161625.

When was PixelShine approved by the FDA?

PixelShine received FDA 510(k) clearance on 2016-09-19, under approval number K161625.

What company makes PixelShine?

PixelShine is manufactured by Algomedica.

What is the FDA product code for PixelShine?

The FDA product code for PixelShine is LLZ.

Related Devices (Code: LLZ)

Official Source

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