Cleared Traditional

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) - FDA 510(k) Clearance

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

K241343 · Shenzhen Lescolton Electrical Appliance Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
57d
Days
Class 2
Risk

K241343 is an FDA 510(k) clearance for the IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T.... Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Lescolton Electrical Appliance Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 9, 2024 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Lescolton Electrical Appliance Co., Ltd. devices

Submission Details

510(k) Number K241343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2024
Decision Date July 09, 2024
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 K241343.
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 (YT01,YT02,YT03,YT04)
K240016 · Shenzhen Jianrong Biomedical Electronics 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
IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)
K240583 · Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. · Jun 2024