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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 Class II Traditional
Decision Date
2024-07-09
Sponsor / Applicant
Shenzhen Lescolton Electrical Appliance Co., Ltd.

Technical Specification

510(k) Submission ID K241343
Product Code OHT
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4810
Decision Date 2024-07-09
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

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) received FDA 510(k) clearance under submission number K241343, sponsored by Shenzhen Lescolton Electrical Appliance 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 2024-07-09.

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.