Cleared Traditional

IPL Hair Removal Device (K222598) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222598 · Shenzhen Noble Smart Manufacturing Tech Co., Ltd. · General & Plastic Surgery device
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Nov 2022
Decision
80d
Days
Class 2
Risk

K222598 is an FDA 510(k) clearance for the IPL Hair Removal Device. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Noble Smart Manufacturing Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 17, 2022 after a review of 80 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 Noble Smart Manufacturing Tech Co., Ltd. devices

Submission Details

510(k) Number K222598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2022
Decision Date November 17, 2022
Days to Decision 80 days
Submission Type Traditional
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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 Reanny Medical Devices Management Consulting Co., Ltd.
Reanny Wang

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 K222598.
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
K223618 · Shenzhen Ulike Smart Electronics Co., Ltd. · Feb 2023
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
Hair Removal Device (Model: IPL-D26, IPL-D19)
K221643 · Shenzhen Desida Technology Co., Ltd. · Oct 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