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FDA 510(k)

Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37

K-Number: K170111 · 2017-05-08

ApplicantPulsaderm, LLC
Decision Date2017-05-08
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 is the device name listed in this FDA 510(k) record. The listed applicant is Pulsaderm, LLC. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K170111. 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 Mask 28 , Pulsaderm Acne Mask 37?

Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is Pulsaderm, LLC. The 510(k) number is K170111.

When did Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 receive FDA 510(k) clearance?

Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 received FDA 510(k) clearance on 2017-05-08, under 510(k) number K170111.

Who is the listed applicant for Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37?

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

What is the FDA product code for Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37?

The FDA product code for Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 is OLP.

Other records listing Pulsaderm, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182501Hair Laser HeadbandK163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72

Related Devices (Code: OLP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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