Cleared Special

IPL Hair Removal (K220927) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K220927 · Shenzhen Qiaochengli Technology Co., Ltd. · General & Plastic Surgery device
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Jun 2022
Decision
63d
Days
Class 2
Risk

K220927 is an FDA 510(k) clearance for the IPL Hair Removal. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Qiaochengli Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 2, 2022 after a review of 63 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shenzhen Qiaochengli Technology Co., Ltd. devices

Submission Details

510(k) Number K220927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2022
Decision Date June 02, 2022
Days to Decision 63 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

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 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 K220927.
IPL Hair Remover, Model: G993, G996, G998 and G885
K221679 · Shenzhen Mywin Technology Co., Ltd. · Jul 2022
Home use hair removal device
K220248 · Shenzhen Mareal Tech Co., Ltd. · Jul 2022
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
K221569 · Shenzhen Fansizhe Science And Technology Co., Ltd. · Jun 2022
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