510(k) K190685
K190685 is an FDA 510(k) premarket notification submitted by Xuzhou Kernel Medical Equipment Co., Ltd. for the device "Hair Growth System". The FDA issued a decision of Substantially Equivalent on July 26, 2019. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Xuzhou Kernel Medical Equipment Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2019
- Date Received
- March 18, 2019
- 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
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v