Cleared Traditional

Home Use IPL Beauty Device (K180016) - FDA 510(k) Clearance

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

K180016 · Shenzhen Mismon Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
77d
Days
Class 2
Risk

K180016 is an FDA 510(k) clearance for the Home Use IPL Beauty Device. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Mismon Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 20, 2018 after a review of 77 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 Mismon Technology Co., Ltd. devices

Submission Details

510(k) Number K180016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2018
Decision Date March 20, 2018
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 K180016.
IPL Hair Removal Device Joy Version
K173813 · Shen Zhen Cosbeauty Co., Ltd. · Sep 2018
Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro
K181121 · Home Well Trading, Ltd. · Jun 2018
Light based hair removal device
K180383 · Shenzhen Gsd Tech Co., Ltd. · May 2018
Home Use Hair Removal Device/T1, T2, T3
K172883 · Shenzhen Mareal Tech Co., Ltd. · Feb 2018
Lumilisse IPL Hair Remover
K172791 · Conair Corporation · Jan 2018