Cleared Traditional

Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. (K210311) - FDA 510(k) Clearance

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

K210311 · Shenzhen Mismon Technology Co., Ltd. · General & Plastic Surgery device
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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

Submission Details

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.

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 K210311.
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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