Cleared Traditional

sensiLight Mini

K161089 · El Global Trade, Ltd. · General & Plastic Surgery
Jul 2016
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K161089 is an FDA 510(k) clearance for the sensiLight Mini, a Light Based Over-the-counter Hair Removal (Class II — Special Controls, product code OHT), submitted by El Global Trade, Ltd. (Netanya, IL). The FDA issued a Cleared decision on July 8, 2016, 81 days after receiving the submission on April 18, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number K161089 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2016
Decision Date July 08, 2016
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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.

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