Cleared Special

K221466 - IPL Hair Removal Device

K221466 is an FDA 510(k) clearance for IPL Hair Removal Device, manufactured by Shenzhen Century Dongyuan Technology CO , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Special 510(k) pathway after a 85-day FDA review.

K221466 · Shenzhen Century Dongyuan Technology CO , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
85d
Days
Class 2
Risk

K221466 is an FDA 510(k) clearance for the IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Century Dongyuan Technology CO , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 12, 2022 after a review of 85 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 Century Dongyuan Technology CO , Ltd. devices

FDA 510(k) Submission Details - K221466

510(k) Number K221466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2022
Decision Date August 12, 2022
Days to Decision 85 days
Submission Type Special
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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

OHT Device Classification - Class 2, Special Controls

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

Qimmiq Medical Consulting Service Co., Ltd.
You Yijie

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 142
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K221466.
IPL Hair Removal Device
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K221635 · Shenzhen Desida Technology Co., Ltd. · Aug 2022
IPL hair removal
K221451 · Shenzhen Lizbella Technology Co.,Ltd · Aug 2022
IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)
K221246 · Shenzhen Semlamp Intelligent Technology Co., Ltd. · Jul 2022
IPL Hair Remover, Model: G993, G996, G998 and G885
K221679 · Shenzhen Mywin Technology Co., Ltd. · Jul 2022