Cleared Traditional

K221643 - Hair Removal Device (Model: IPL-D26

K221643 is the FDA 510(k) clearance for Hair Removal Device (Model: IPL-D26 by Shenzhen Desida Technology Co., Ltd.. It is a Class 2 General & Plastic Surgery device (product code OHT) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K221643 · Shenzhen Desida Technology Co., Ltd. · General & Plastic Surgery device
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Oct 2022
Decision
137d
Days
Class 2
Risk

K221643 is an FDA 510(k) clearance for the Hair Removal Device (Model: IPL-D26, IPL-D19). Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Desida Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 21, 2022 after a review of 137 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Desida Technology Co., Ltd. devices

Submission Details

510(k) Number K221643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2022
Decision Date October 21, 2022
Days to Decision 137 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
22d slower than avg
Panel avg: 115d · This submission: 137d
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

Shenzhen CT Bio-Tech Co., Ltd.
Amos Zou

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 K221643.
IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
K223524 · Morlaser Shenzhen Co., Ltd. · Feb 2023
IPL Cooling Hair Removal Device
K222710 · Shenzhen Siken 3D Technology Development Co., Ltd. · Dec 2022
IPL Hair Removal Device
K222598 · Shenzhen Noble Smart Manufacturing Tech Co., Ltd. · Nov 2022
IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
K222537 · Shenzhen Ishine Technology Company Limited · Oct 2022
IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
K222432 · Hunan Guangye Biotechnology Co., Ltd. · Oct 2022
IPL Hair Removal Device
K222316 · Shenzhen Goodwind Technology Development Co., Ltd. · Sep 2022