Cleared Special

K230911 - Braun Skin i.expert

K230911 is the FDA 510(k) clearance for Braun Skin i.expert by Cyden Limited. It is a Class 2 General & Plastic Surgery device (product code OHT) cleared through the Special 510(k) pathway after a 27-day FDA review.

K230911 · Cyden Limited · General & Plastic Surgery device
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Apr 2023
Decision
27d
Days
Class 2
Risk

K230911 is an FDA 510(k) clearance for the Braun Skin i.expert. 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 April 27, 2023 after a review of 27 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.

View all Cyden Limited devices

Submission Details

510(k) Number K230911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2023
Decision Date April 27, 2023
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K230911.
IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
K231215 · Zhongshan Qizhe Technology Co., Ltd. · Jun 2023
IPL Hair Removal Device Models: MLY-T069
K230473 · Miley Technology (Hebei) Co., Ltd. · Jun 2023
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
K230739 · Shenzhen Ionka Medical Technology Co., Ltd. · May 2023
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
K230549 · Shenzhen Xiazhifeng Electronic Co., Ltd. · Apr 2023
Diode Laser Hair Removal
K230090 · Wuhan Lotuxs Technology Co., Ltd. · Apr 2023
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
K230122 · Shenzhen Ulike Smart Electronics Co., Ltd. · Apr 2023