LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)— 510(k) K241857
Substantially EquivalentDongguan Boyuan Intelligent Technology Co.,Ltd
FDA 510(k) clearance K241857 for LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293), Substantially Equivalent on 2024-10-11. Applicant: Dongguan Boyuan Intelligent Technology Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Dongguan Boyuan Intelligent Technology Co.,Ltd
- Product code
- Code OHS
- 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 OHS
view allMore clearances from Dongguan Boyuan Intelligent Technology Co.,Ltd
view all- K250253 — IPL Hair Removal Device (KCA511/KCA516/KCA522)
- 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)
- K240282 — IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)
Adverse events under product code OHS
product code OHS- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.