Cleared Traditional

K210311 - Home Use IPL Beauty Device

K210311 is an FDA 510(k) clearance for Home Use IPL Beauty Device, manufactured by Shenzhen Mismon Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K210311 · Shenzhen Mismon Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
170d
Days
Class 2
Risk

K210311 is an FDA 510(k) clearance for the Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MEL.... 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 July 23, 2021 after a review of 170 days - an extended review 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: 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 Mismon Technology Co., Ltd. devices

FDA 510(k) Submission Details - K210311

510(k) Number K210311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2021
Decision Date July 23, 2021
Days to Decision 170 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
55d slower than avg
Panel avg: 115d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OHT Device Classification - Class 2, Special Controls

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 142
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K210311.
IPL Home Use Hair Removal Device
K211922 · Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. · Sep 2021
IPL Hair Removal
K211174 · Shenzhen Qiaochengli Technology Co., Ltd. · Sep 2021
Braun Silk.expert Mini
K211994 · Cyden Limited · Jul 2021
IPL Hair removal
K203510 · Shenzhen Weikai Technology Co.,Ltd · Feb 2021
SmoothSkin Pure
K200184 · Cyden Limited · Feb 2020
IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
K192432 · Shenzhen Bosidin Technology Co., Ltd. · Nov 2019