510(k) K241342
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 2024
- Date Received
- May 13, 2024
- 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