Cleared Special

K211994 - Braun Silk.expert Mini

K211994 is an FDA 510(k) clearance for Braun Silk.expert Mini, manufactured by Cyden Limited. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Special 510(k) pathway after a 30-day FDA review.

K211994 · Cyden Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
30d
Days
Class 2
Risk

K211994 is an FDA 510(k) clearance for the Braun Silk.expert Mini. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Cyden Limited (Swansea, GB). The FDA issued a Cleared decision on July 28, 2021 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K211994

510(k) Number K211994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2021
Decision Date July 28, 2021
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 166
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K211994.
Superior Hair Remover
K210376 · Guangzhou Haoxingwan Technology Co., Ltd. · Oct 2021
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
Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.
K210311 · Shenzhen Mismon Technology Co., Ltd. · Jul 2021
IPL Hair removal
K203510 · Shenzhen Weikai Technology Co.,Ltd · Feb 2021
SmoothSkin Pure
K200184 · Cyden Limited · Feb 2020
K211994 · Braun Silk.expert Mini
Download PDF Cyden Limited