CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)— 510(k) K251017
Substantially EquivalentShenzhen Kaiyan Medical Equipment Co., Ltd.
FDA 510(k) clearance K251017 for CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A), Substantially Equivalent on 2025-06-17. Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Product code
- 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
- Shenzhen, CN
Recent devices under product code OAP
view all- 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)
- K253231 — Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
- K260899 — Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
- K251684 — Alma TED+ System
More clearances from Shenzhen Kaiyan Medical Equipment Co., Ltd.
view all- K253932 — FACEGYM Pro Device (HD-109)
- K254025 — LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
- K260688 — Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
- K260129 — Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
- K253878 — LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
Data sourced from openFDA. This site is unofficial and independent of the FDA.