510(k) K180617
K180617 is an FDA 510(k) premarket notification submitted by Y & J Bio Co., Ltd. for the device "Hair Up". The FDA issued a decision of Substantially Equivalent on Jun 1, 2018. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Y & J Bio Co., Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 1, 2018
- Date Received
- Mar 8, 2018
- 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)
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v