IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)— 510(k) K260594
Substantially EquivalentShenzhen Xiazhifeng Electronic Co., Ltd.
FDA 510(k) clearance K260594 for IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM), Substantially Equivalent on 2026-05-20. Applicant: Shenzhen Xiazhifeng Electronic Co., Ltd.. Device class: 2.
Summary
Shenzhen Xiazhifeng Electronic's IPL Hair Removal Device is listed with 24 model numbers, FL-B505AG through FL-B513AM. It's filed under OHT, light based over-the-counter hair removal. Apart from the model numbers, the name is generic.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Xiazhifeng filed from Shenzhen, China. Review took 86 calendar days (February 23 to May 20, 2026).
Clearance details
- Applicant
- Shenzhen Xiazhifeng Electronic 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
- Shenzhen, CN
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More clearances from Shenzhen Xiazhifeng Electronic Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.