Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)— 510(k) K250308
Substantially EquivalentDongguan Boyuan Intelligent Technology Co.,Ltd
FDA 510(k) clearance K250308 for Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S), Substantially Equivalent on 2025-04-29. Applicant: Dongguan Boyuan Intelligent Technology Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Dongguan Boyuan Intelligent Technology Co.,Ltd
- Product code
- Product code OAP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, CN
Recent devices under product code OAP
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- K262183 — Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)
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- K261675 — CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)
- K261253 — Laser 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)
More clearances from Dongguan Boyuan Intelligent Technology Co.,Ltd
view allData sourced from openFDA. This site is unofficial and independent of the FDA.