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FDA PRODUCT CODE · CLASS II

OHT — Light Based Over-The-Counter Hair Removal

Over-the-counter device uses thermal energy to kill hair follicles for hair removal.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4810
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
40
510(K)/PMA CLEARANCES
510k: 40
0
RECALL ENTRIES

Recent clearances

K261325Shenzhen Ulike Smart Electronics Co., Ltd. · 510k2026-05-21
K260594Shenzhen Xiazhifeng Electronic Co., Ltd. · 510k2026-05-20
K260742Shenzhen Ulike Smart Electronics Co., Ltd. · 510k2026-05-05
K260518Shenzhen Semlamp Intelligent Technology Co., Ltd. · 510k2026-04-21
K254047Shenzhen Chuangtong Yigou Technology Co., Ltd. · 510k2026-03-11
K253666Shenzhen Mlay Intelligent Technology Co., Ltd. · 510k2026-02-23
K253881Shenzhen Fansizhe Science and Technology Co., Ltd. · 510k2025-12-29
K253754Philips Consumer Lifestyle B.V. · 510k2025-12-23

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

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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