510(k) K240472
K240472 is an FDA 510(k) premarket notification submitted by Dongguan Tutamen Metalwork Co., Ltd. for the device "PBM Hair Therapy Cap". The FDA issued a decision of Substantially Equivalent on October 11, 2024. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Dongguan Tutamen Metalwork Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 2024
- Date Received
- February 20, 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