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FDA 510(k)

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)

K-Number: K230124 · 2023-03-15

ApplicantLight Tree Ventures Europe B.V.
Decision Date2023-03-15
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) is a medical device manufactured by Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2023-03-15 under approval number K230124. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)?

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) is a medical device that received FDA 510(k) clearance on 2023-03-15. It is manufactured by Light Tree Ventures Europe B.V.. The 510(k) number is K230124.

When was LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) approved by the FDA?

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) received FDA 510(k) clearance on 2023-03-15, under approval number K230124.

What company makes LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)?

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) is manufactured by Light Tree Ventures Europe B.V..

What is the FDA product code for LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)?

The FDA product code for LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) is OHS.

Other Devices by Light Tree Ventures Europe B.V.

K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) K221444LED Eye Perfector, model: EY-36A, EY-36B K221946LED Light Therapy Mask (model: MK66R-B) K222205Cold Sore Device (Model: QPZ-01) K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 K223893Infrared Heat (Model: E0221)

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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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