510(k) K262834
K262834 is an FDA 510(k) premarket notification submitted by Shenzhen Jianchao Intelligent Technology Co., Ltd. for the device "Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)". The FDA issued a decision of Substantially Equivalent on Oct 9, 2026. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Shenzhen Jianchao Intelligent Technology Co., Ltd. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 9, 2026
- Date Received
- Aug 11, 2026
- 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