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FDA 510(k)

Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352

K-Number: K163170 · 2017-01-31

ApplicantCapillus, LLC
Decision Date2017-01-31
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 is the device name listed in this FDA 510(k) record. The listed applicant is Capillus, LLC. It received FDA 510(k) clearance on 2017-01-31 under 510(k) number K163170. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352?

Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 is a medical device that received FDA 510(k) clearance on 2017-01-31. The listed applicant is Capillus, LLC. The 510(k) number is K163170.

When did Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 receive FDA 510(k) clearance?

Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 received FDA 510(k) clearance on 2017-01-31, under 510(k) number K163170.

Who is the listed applicant for Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352?

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

What is the FDA product code for Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352?

The FDA product code for Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 is OAP.

Other records listing Capillus, 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.

Related Devices (Code: OAP)

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.

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.