Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K230597 · 2023-04-28

ApplicantLight Tree Ventures Europe B.V.
Decision Date2023-04-28
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) 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 2023-04-28 under 510(k) number K230597. 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 Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)?

Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) is a medical device that received FDA 510(k) clearance on 2023-04-28. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K230597.

When did Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) receive FDA 510(k) clearance?

Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) received FDA 510(k) clearance on 2023-04-28, under 510(k) number K230597.

Who is the listed applicant for Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)?

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

The FDA product code for Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) 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.

K260415myLEDmask 2 (MJ-144)K253349Hair Regrowth Cap (Model: T-119-HRC)K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001K223893Infrared Heat (Model: E0221)K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)K230336CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)

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.

K261675CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)Shenzhen Chuanghong Zhilian Technology Co., Ltd.K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)Ziree Co., Ltd.K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)Zdeer Technology (Henan) Co., Ltd.K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)Hubei Yjt Technology Co.,LtdK251684Alma TED+ SystemAlma Lasers, Inc.K253669TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd.

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.

↑