510(k) K260899
K260899 is an FDA 510(k) premarket notification submitted by Zdeer Technology (Henan) Co., Ltd. for the device "Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)". The FDA issued a decision of Substantially Equivalent on June 16, 2026. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Zdeer Technology (Henan) Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2026
- Date Received
- March 18, 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
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v