IPL Hair Removal Device (KCA511/KCA516/KCA522)— 510(k) K250253
Substantially EquivalentDongguan Boyuan Intelligent Technology Co.,Ltd
FDA 510(k) clearance K250253 for IPL Hair Removal Device (KCA511/KCA516/KCA522), Substantially Equivalent on 2025-05-06. Applicant: Dongguan Boyuan Intelligent Technology Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Dongguan Boyuan Intelligent Technology Co.,Ltd
- Product code
- Product code OHT
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, CN
Recent devices under product code OHT
view all- K262352 — IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)
- K261975 — Braun Aura 7 (6041)
- K261977 — Braun Aura 9 (6042)
- K262524 — Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
- K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
More clearances from Dongguan Boyuan Intelligent Technology Co.,Ltd
view all- K250308 — Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
- K241857 — LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
- K240282 — IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)
Data sourced from openFDA. This site is unofficial and independent of the FDA.