← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
OAP — Laser, Comb, Hair
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
DEVICE CLASS
Class II
REGULATION
21 CFR 890.5500
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
18
510(K)/PMA CLEARANCES
510k: 18
0
RECALL ENTRIES
Recent clearances
K261675Shenzhen Chuanghong Zhilian Technology Co., Ltd. · 510k2026-07-17
K261253Ziree Co., Ltd. · 510k2026-06-26
K260899Zdeer Technology (Henan) Co., Ltd. · 510k2026-06-16
K253231Hubei Yjt Technology Co.,Ltd · 510k2026-06-16
K251684Alma Lasers, Inc. · 510k2026-06-05
K253669Shenzhen Kaiyan Medical Equipment Co., Ltd. · 510k2026-01-23
K253349Light Tree Ventures Europe B.V. · 510k2025-12-24
K252414Shenzhen Kaiyan Medical Equipment Co., Ltd. · 510k2025-10-30
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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