Cleared Traditional

IPL Hair Removal, Model: OBT-02 (K213041) - FDA 510(k) Clearance

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

K213041 · Glan Electronics Co., Ltd. · General & Plastic Surgery device
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Nov 2021
Decision
57d
Days
Class 2
Risk

K213041 is an FDA 510(k) clearance for the IPL Hair Removal, Model: OBT-02. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Glan Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 18, 2021 after a review of 57 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 Glan Electronics Co., Ltd. devices

Submission Details

510(k) Number K213041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2021
Decision Date November 18, 2021
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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

Sgs-Cstc Standards Technical Services Co., Ltd.
Iris Fung

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 K213041.
IPL Home Use Hair Removal Device
K211185 · Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. · Dec 2021
IPL hair removal machine
K213020 · Shenzhen Borria Technology Co., Ltd. · Dec 2021
Leaf Smooth
K212697 · Shenzhen Leaflife Technology Co., Ltd. · Nov 2021
IPL Hair Removal Device, model: AI01
K212897 · Shenzhen Century Dongyuan Technology CO , Ltd. · Nov 2021
IPL Hair Removal Device
K212314 · Zhongshan Bisen Plastic Electronic Products Co., Ltd. · Oct 2021
Superior Hair Remover
K210376 · Guangzhou Haoxingwan Technology Co., Ltd. · Oct 2021