510(k) K220543
K220543 is an FDA 510(k) premarket notification submitted by Auxo Hair, LLC for the device "Auxo A300, A150 and APod". The FDA issued a decision of Substantially Equivalent on Apr 20, 2022. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 20, 2022
- Date Received
- Feb 25, 2022
- Clearance Type
- Traditional
- 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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