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FDA 510(k)

Hair Regrowth Cap (Model: T-119-HRC)

K-Number: K253349 · 2025-12-24

Decision Date2025-12-24
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Hair Regrowth Cap (Model: T-119-HRC) is the device name listed in this FDA 510(k) record. The listed applicant is Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2025-12-24 under 510(k) number K253349. 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 Hair Regrowth Cap (Model: T-119-HRC)?

Hair Regrowth Cap (Model: T-119-HRC) is a medical device that received FDA 510(k) clearance on 2025-12-24. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K253349.

When did Hair Regrowth Cap (Model: T-119-HRC) receive FDA 510(k) clearance?

Hair Regrowth Cap (Model: T-119-HRC) received FDA 510(k) clearance on 2025-12-24, under 510(k) number K253349.

Who is the listed applicant for Hair Regrowth Cap (Model: T-119-HRC)?

The FDA 510(k) record lists Light Tree Ventures Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hair Regrowth Cap (Model: T-119-HRC)?

The FDA product code for Hair Regrowth Cap (Model: T-119-HRC) is OAP.

Other records listing Light Tree Ventures Europe B.V. 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.

View all 13 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.