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FDA 510(k)

Pixie Skin Tag

K-Number: K240226 · 2024-10-18

ApplicantOystershell NV
Decision Date2024-10-18
Product CodeORE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pixie Skin Tag is the device name listed in this FDA 510(k) record. The listed applicant is Oystershell NV. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K240226. The device is classified under product code ORE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pixie Skin Tag?

Pixie Skin Tag is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Oystershell NV. The 510(k) number is K240226.

When did Pixie Skin Tag receive FDA 510(k) clearance?

Pixie Skin Tag received FDA 510(k) clearance on 2024-10-18, under 510(k) number K240226.

Who is the listed applicant for Pixie Skin Tag?

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

What is the FDA product code for Pixie Skin Tag?

The FDA product code for Pixie Skin Tag is ORE.

Related Clinical Trials

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.

NCT07660354Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).RECRUITING

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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