Cleared Traditional

Hand-held IPL device (JOVS Hair Removal Device)

K220645 · Shenzhen Qianyu Technology Co., Ltd. · General & Plastic Surgery
Apr 2022
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K220645 is an FDA 510(k) clearance for the Hand-held IPL device (JOVS Hair Removal Device), a Light Based Over-the-counter Hair Removal (Class II — Special Controls, product code OHT), submitted by Shenzhen Qianyu Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 27, 2022, 54 days after receiving the submission on March 4, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number K220645 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2022
Decision Date April 27, 2022
Days to Decision 54 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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