510(k) K231613

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. by Zhuzhou Goldenhot Medical Technology Co., Ltd. — Product Code OHT

K231613 is an FDA 510(k) premarket notification submitted by Zhuzhou Goldenhot Medical Technology Co., Ltd. for the device "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.". The FDA issued a decision of Substantially Equivalent on July 31, 2023. The device falls under product code OHT (Light Based Over-The-Counter Hair Removal), a Class II device regulated under 21 CFR 878.4810. Zhuzhou Goldenhot Medical Technology Co., Ltd. has at least 2 other 510(k) clearances on record.