Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)— 510(k) K260899
Substantially EquivalentZdeer Technology (Henan) Co., Ltd.
FDA 510(k) clearance K260899 for Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159), Substantially Equivalent on 2026-06-16. Applicant: Zdeer Technology (Henan) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Zdeer Technology (Henan) 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
- Changge, Xuchang City, 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)
- K251684 — Alma TED+ System
- K253669 — TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)
More clearances from Zdeer Technology (Henan) Co., Ltd.
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