Cleared Traditional

IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)

K240282 · Dongguan Boyuan Intelligent Technology Co.,Ltd · General & Plastic Surgery

Apr 2024

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K240282 is an FDA 510(k) clearance for the IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521), a Light Based Over-the-counter Hair Removal (Class II — Special Controls, product code OHT), submitted by Dongguan Boyuan Intelligent Technology Co.,Ltd (Dongguan, CN). The FDA issued a Cleared decision on April 3, 2024, 62 days after receiving the submission on February 1, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K240282 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2024
Decision Date	April 03, 2024
Days to Decision	62 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	OHT — Light Based Over-the-counter Hair Removal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal.