K241343 is an FDA 510(k) clearance for the 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). This device is classified as a Light Based Over-the-counter Hair Removal (Class II - Special Controls, product code OHT).
Submitted by Shenzhen Lescolton Electrical Appliance Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 9, 2024, 57 days after receiving the submission on May 13, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal..
| 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 |
| Product Code | OHT - Light Based Over-the-counter Hair Removal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal. |