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FDA 510(k)

Pulsaderm ACE-All Blue

K-Number: K162371 · 2016-12-15

ApplicantNutra Luxe MD, LLC
Decision Date2016-12-15
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pulsaderm ACE-All Blue is a medical device manufactured by Nutra Luxe MD, LLC. It received FDA 510(k) clearance on 2016-12-15 under approval number K162371. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pulsaderm ACE-All Blue?

Pulsaderm ACE-All Blue is a medical device that received FDA 510(k) clearance on 2016-12-15. It is manufactured by Nutra Luxe MD, LLC. The 510(k) number is K162371.

When was Pulsaderm ACE-All Blue approved by the FDA?

Pulsaderm ACE-All Blue received FDA 510(k) clearance on 2016-12-15, under approval number K162371.

What company makes Pulsaderm ACE-All Blue?

Pulsaderm ACE-All Blue is manufactured by Nutra Luxe MD, LLC.

What is the FDA product code for Pulsaderm ACE-All Blue?

The FDA product code for Pulsaderm ACE-All Blue is OLP.

Other Devices by Nutra Luxe MD, LLC

K161941Pulsaderm Acne Device K160728NutraStim Hair Laser Helmet K150826Nutra Face Lift Model PE8050

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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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