510(k) K192425
K192425 is an FDA 510(k) premarket notification submitted by Wontech Co., Ltd. for the device "Hair Boom 69, Hair Boom Air, Ulike Hair UpUp". The FDA issued a decision of Substantially Equivalent on Sep 30, 2019. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Wontech Co., Ltd. has 27 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 2019
- Date Received
- Sep 5, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Comb, Hair
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- SU
- Submission Type
- 510(k)
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