Cleared Traditional

K230549 - IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG (FDA 510(k) Clearance)

K230549 · Shenzhen Xiazhifeng Electronic Co., Ltd. · General & Plastic Surgery device

Apr 2023

Decision

56d

Days

Class 2

Risk

K230549 is an FDA 510(k) clearance for the IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG. This device is classified as a Light Based Over-the-counter Hair Removal (Class II - Special Controls, product code OHT).

Submitted by Shenzhen Xiazhifeng Electronic Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 25, 2023, 56 days after receiving the submission on February 28, 2023.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal..

Submission Details

510(k) Number	K230549 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 28, 2023
Decision Date	April 25, 2023
Days to Decision	56 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

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.