Cleared Traditional

K181121 - Beurer IPL 5500 device/ IPL 5000/ IPL P...

K181121 is the FDA 510(k) clearance for Beurer IPL 5500 device/ IPL 5000/ IPL P... by Home Well Trading, Ltd.. It is a Class 2 General & Plastic Surgery device (product code OHT) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K181121 · Home Well Trading, Ltd. · General & Plastic Surgery device
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Jun 2018
Decision
59d
Days
Class 2
Risk

K181121 is an FDA 510(k) clearance for the Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Home Well Trading, Ltd. (Tortola, VG). The FDA issued a Cleared decision on June 28, 2018 after a review of 59 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 Home Well Trading, Ltd. devices

Submission Details

510(k) Number K181121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2018
Decision Date June 28, 2018
Days to Decision 59 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
56d faster than avg
Panel avg: 115d · This submission: 59d
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 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 K181121.
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Home Use IPL Beauty Device
K180016 · Shenzhen Mismon Technology Co., Ltd. · Mar 2018
Home Use Hair Removal Device/T1, T2, T3
K172883 · Shenzhen Mareal Tech Co., Ltd. · Feb 2018