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FDA 510(k)

HAIRMAX DUAL 12

K-Number: K111714 · 2011-08-16

ApplicantLexington International, LLC
Decision Date2011-08-16
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HAIRMAX DUAL 12 is the device name listed in this FDA 510(k) record. The listed applicant is Lexington International, LLC. It received FDA 510(k) clearance on 2011-08-16 under 510(k) number K111714. 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 HAIRMAX DUAL 12?

HAIRMAX DUAL 12 is a medical device that received FDA 510(k) clearance on 2011-08-16. The listed applicant is Lexington International, LLC. The 510(k) number is K111714.

When did HAIRMAX DUAL 12 receive FDA 510(k) clearance?

HAIRMAX DUAL 12 received FDA 510(k) clearance on 2011-08-16, under 510(k) number K111714.

Who is the listed applicant for HAIRMAX DUAL 12?

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

What is the FDA product code for HAIRMAX DUAL 12?

The FDA product code for HAIRMAX DUAL 12 is OAP.

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Other records listing Lexington International, LLC as applicant

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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.

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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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