Cleared Traditional

K221635 - IPL sapphire ice cooling hair remove de...

K221635 is the FDA 510(k) clearance for IPL sapphire ice cooling hair remove de... 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 86-day FDA review.

K221635 · Shenzhen Desida Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
86d
Days
Class 2
Risk

K221635 is an FDA 510(k) clearance for the IPL sapphire ice cooling hair remove device. 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 August 31, 2022 after a review of 86 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 Desida Technology Co., Ltd. devices

Submission Details

510(k) Number K221635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2022
Decision Date August 31, 2022
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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

Feiying Drug & Medical Consulting Technical Service Group
Rain Yip

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 K221635.
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
Diamond Air+ (UI04A, UI04B, UI04C)
K221553 · Ulike Co., Ltd. · Sep 2022
IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
K221466 · Shenzhen Century Dongyuan 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