Cleared Traditional

IPL Hair Removal Device (YT01,YT02,YT03,YT04) (K240016) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240016 · Shenzhen Jianrong Biomedical Electronics Co., Ltd. · General & Plastic Surgery device
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Jul 2024
Decision
190d
Days
Class 2
Risk

K240016 is an FDA 510(k) clearance for the IPL Hair Removal Device (YT01,YT02,YT03,YT04). Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Jianrong Biomedical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 10, 2024 after a review of 190 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Jianrong Biomedical Electronics Co., Ltd. devices

Submission Details

510(k) Number K240016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2024
Decision Date July 10, 2024
Days to Decision 190 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 115d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OHT Light Based Over-the-counter Hair Removal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OHT Light Based Over-the-counter Hair Removal

All 141
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K240016.
IPL Hair Removal Device (BE932C, BE932D, BE932E)
K241834 · Shenzhen Yang WO Electronic Co., Ltd. · Sep 2024
Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
K241205 · Shenzhen Ulike Smart Electronics Co., Ltd. · Sep 2024
IPL Hair Removal Device (JM-843, JM-865, JM-638)
K241881 · Shenzhen Junmei Technology Co., Ltd. · Aug 2024
IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)
K241343 · Shenzhen Lescolton Electrical Appliance Co., Ltd. · Jul 2024
Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
K241120 · Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. · Jun 2024
Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)
K240649 · Shenzhen Ulike Smart Electronics Co., Ltd. · Jun 2024