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CurrentBody Skin LED Hair Regrowth (Model: MZ-07)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230336

by Light Tree Ventures Europe B.V.

Identifiers

510(k) Number
K230336 FDA 510(k)
FDA Product Code
OAP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5500 FDA 510(k)
Regulation Number
890.5500 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CurrentBody Skin LED Hair Regrowth (Model: MZ-07) is a low-level laser therapy device classified as a laser comb for hair. It emits specific wavelengths of light to stimulate hair follicles, intended for non-invasive hair regrowth treatment in individuals experiencing hair thinning or loss.

This device is supplied as a reusable, non-sterile medical instrument designed for home or clinical use. It operates within Class II regulatory controls under FDA 510(k) clearance (K230336) and is intended for use in physical medicine settings. The device requires no special storage conditions beyond its original packaging and is not MRI-compatible. No additional authorisations beyond the stated FDA clearance are referenced.

Frequently asked questions

What is the CurrentBody Skin LED Hair Regrowth device used for and how does it work?

The CurrentBody Skin LED Hair Regrowth (Model MZ-07) is a low-level laser therapy device designed as a laser comb for hair. It emits specific wavelengths of light to stimulate hair follicles, aiming to promote non-invasive hair regrowth in individuals experiencing thinning or hair loss. The device operates on the principle of low-level laser therapy, which is intended to encourage follicle activity without surgical intervention.

Is the CurrentBody Skin LED Hair Regrowth device meant for home use or only clinical settings?

The device is explicitly designed for both home and clinical use, as stated in its description. It is a reusable, non-sterile medical instrument, making it suitable for patient self-administration at home or integration into physical medicine treatment plans in a clinical environment.

How should I store the CurrentBody Skin LED Hair Regrowth device, and does it require any special conditions?

The device does not require special storage conditions beyond keeping it in its original packaging. Since it is reusable and non-sterile, it should be stored in a clean, dry environment to maintain its functionality and hygiene until use.

Can the CurrentBody Skin LED Hair Regrowth device be used in an MRI environment?

No, the device is explicitly stated as not MRI-compatible. If used in or near an MRI facility, it should be removed or stored outside the MRI environment to avoid potential interference or safety risks.

What regulatory pathway was followed for the CurrentBody Skin LED Hair Regrowth device, and what does that mean for its use?

The device underwent a traditional 510(k) clearance process through the FDA, classified under Class II regulatory controls and filed under the Physical Medicine advisory committee. This means it was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use in physical medicine settings, such as hair regrowth treatment.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07) (K230336) — FDA 510 ..., K230336 - CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07), PDF April 5, 2023 Light Tree Ventures Europe B.V.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Light Tree Ventures Europe B.V.

Sources (1)

  • FDA 510(k) K230336 24 fields · synced Sep 19, 2026