K181568 - IPL Salon Hair Reduction System (FDA 510(k) Clearance)

K181568 is an FDA 510(k) clearance for the IPL Salon Hair Reduction System. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt (Zhangzhou, CN). The FDA issued a Cleared decision on September 11, 2018 after a review of 89 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.