K231613 is an FDA 510(k) clearance for the Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.. This device is classified as a Light Based Over-the-counter Hair Removal (Class II - Special Controls, product code OHT).
Submitted by Zhuzhou Goldenhot Medical Technology Co., Ltd. (Zhuzhou, CN). The FDA issued a Cleared decision on July 31, 2023, 59 days after receiving the submission on June 2, 2023.
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 | K231613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2023 |
| Decision Date | July 31, 2023 |
| Days to Decision | 59 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. |