Cleared Traditional

CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07) (K230336) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230336 · Light Tree Ventures Europe B.V. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
57d
Days
Class 2
Risk

K230336 is an FDA 510(k) clearance for the CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07). Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Light Tree Ventures Europe B.V. (Hague, NL). The FDA issued a Cleared decision on April 5, 2023 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Light Tree Ventures Europe B.V. devices

Submission Details

510(k) Number K230336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2023
Decision Date April 05, 2023
Days to Decision 57 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAP Laser, Comb, Hair
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
Definition Promote Hair Growth In Males With Androgenic Alopecia And Norwood Hamilton Classification Of Iia To V
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OAP Laser, Comb, Hair

All 71
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K230336.
Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
K230134 · Hubei Yjt Technology Co.,Ltd · May 2023
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
K223862 · Wontech Co., Ltd. · Apr 2023
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
K230597 · Light Tree Ventures Europe B.V. · Apr 2023
Hair Growth Device
K222477 · Dongguan Lescolton Medical Equipment Co., Ltd. · Nov 2022
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
K222364 · Xtrallux, LLC · Nov 2022
ID-510 iRestore Elite
K222081 · Freedom Laser Therapy, Inc. · Oct 2022