Cleared Traditional

Hand-held IPL device (JOVS Hair Removal Device) (K220645) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K220645 is an FDA 510(k) clearance for the Hand-held IPL device (JOVS Hair Removal Device). Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Qianyu Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 27, 2022 after a review of 54 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.

View all Shenzhen Qianyu Technology Co., Ltd. devices

Submission Details

510(k) Number K220645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 115d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OHT Light Based Over-the-counter Hair Removal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Guangzhou Tianke Testing Technology Service Co., Ltd.
Klem Hou

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OHT Light Based Over-the-counter Hair Removal

All 141
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K220645.
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
K221002 · Shenzhen Ulike Smart Electronics Co., Ltd. · Jun 2022
IPL HAIR REMOVAL HANDSET, Model: IPL-666
K220669 · Shenzhen Junbobeauty Technology Co., Ltd. · May 2022
IPL Home Use Hair Removal Device
K221001 · Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. · May 2022
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
K220222 · Shenzhen Yuwei Electronic Technology Co., Ltd. · Apr 2022
Intense Pulsed Light (IPL) System
K212881 · Shenzhen Fansizhe Science And Technology Co., Ltd. · Apr 2022
Hand-held IPL device(JOVS Graphene Hair Removal Device)
K214113 · Shenzhen Qianyu Technology Co., Ltd. · Mar 2022