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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

K230549 Class II Traditional
Decision Date
2023-04-25
Sponsor / Applicant
Shenzhen Xiazhifeng Electronic Co., Ltd.

Technical Specification

510(k) Submission ID K230549
Product Code OHT
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4810
Decision Date 2023-04-25
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

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 received FDA 510(k) clearance under submission number K230549, sponsored by Shenzhen Xiazhifeng Electronic Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-04-25.

Classification & Regulation

This clearance is catalogued under FDA product code OHT and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.