Cleared Traditional

K221643 - Hair Removal Device (Model: IPL-D26, IPL-D19)

K221643 is an FDA 510(k) clearance for Hair Removal Device (Model: IPL-D26, manufactured by Shenzhen Desida Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K221643

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.

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

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 161
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