Hair Up— 510(k) K180617
Substantially EquivalentY & J Bio Co., Ltd.
FDA 510(k) clearance K180617 for Hair Up, Substantially Equivalent on 2018-06-01. Applicant: Y & J Bio Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Y & J Bio 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
- Seoul, KR
Recent devices under product code OAP
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- 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)
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More clearances from Y & J Bio Co., Ltd.
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