Cleared Traditional

Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)

K230597 · Light Tree Ventures Europe B.V. · General & Plastic Surgery

Apr 2023

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K230597 is an FDA 510(k) clearance for the Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B), a Laser, Comb, Hair (Class II — Special Controls, product code OAP), submitted by Light Tree Ventures Europe B.V. (Hague, NL). The FDA issued a Cleared decision on April 28, 2023, 56 days after receiving the submission on March 3, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K230597 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 2023
Decision Date	April 28, 2023
Days to Decision	56 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OAP — Laser, Comb, Hair
Device Class	Class II — 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