Cleared Traditional

IPL Hair Removal Device (BE932C, BE932D, BE932E) (K241834) - FDA 510(k) Clearance

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

K241834 · Shenzhen Yang WO Electronic Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
90d
Days
Class 2
Risk

K241834 is an FDA 510(k) clearance for the IPL Hair Removal Device (BE932C, BE932D, BE932E). Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Yang WO Electronic Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 23, 2024 after a review of 90 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 Yang WO Electronic Co., Ltd. devices

Submission Details

510(k) Number K241834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2024
Decision Date September 23, 2024
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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
Riley Chen

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 K241834.
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
K242039 · Shenzhen Ulike Smart Electronics Co., Ltd. · Nov 2024
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
K243030 · Ulike Co., Ltd. · Oct 2024
IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
K242197 · Shenzhen Huaruibo Electric Appliances Co., Ltd. · Oct 2024
Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
K241205 · Shenzhen Ulike Smart Electronics Co., Ltd. · Sep 2024
IPL Hair Removal Device (JM-843, JM-865, JM-638)
K241881 · Shenzhen Junmei Technology Co., Ltd. · Aug 2024
IPL Hair Removal Device (YT01,YT02,YT03,YT04)
K240016 · Shenzhen Jianrong Biomedical Electronics Co., Ltd. · Jul 2024