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FDA 510(k)

Pulsaderm Acne Device

K-Number: K161941 · 2016-10-19

ApplicantNutra Luxe MD, LLC
Decision Date2016-10-19
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pulsaderm Acne Device is a medical device manufactured by Nutra Luxe MD, LLC. It received FDA 510(k) clearance on 2016-10-19 under approval number K161941. 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 Acne Device?

Pulsaderm Acne Device is a medical device that received FDA 510(k) clearance on 2016-10-19. It is manufactured by Nutra Luxe MD, LLC. The 510(k) number is K161941.

When was Pulsaderm Acne Device approved by the FDA?

Pulsaderm Acne Device received FDA 510(k) clearance on 2016-10-19, under approval number K161941.

What company makes Pulsaderm Acne Device?

Pulsaderm Acne Device is manufactured by Nutra Luxe MD, LLC.

What is the FDA product code for Pulsaderm Acne Device?

The FDA product code for Pulsaderm Acne Device is OLP.

Other Devices by Nutra Luxe MD, LLC

K162371Pulsaderm ACE-All Blue K160728NutraStim Hair Laser Helmet K150826Nutra Face Lift Model PE8050

Related Devices (Code: OLP)

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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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