Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
FDA 510(k) K230597 · Light Tree Ventures Europe B.V.
510(k) numberK230597
Submission
- Device name
- Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
- Applicant
- Light Tree Ventures Europe B.V.
Hague, NL - Received
- March 3, 2023
- Decision date
- April 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAP – Laser, Comb, Hair
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
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Questions and answers
When was Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) cleared by the FDA?
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) (K230597) received a 510(k) decision of Substantially Equivalent on April 28, 2023, 56 days after the submission was received.
What is the product code of K230597?
The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.