Cleared Special

K243362 - SmoothSkin Pure Switch (SSC1)

K243362 is the FDA 510(k) clearance for SmoothSkin Pure Switch (SSC1) by Cyden Limited. It is a Class 2 General & Plastic Surgery device (product code OHT) cleared through the Special 510(k) pathway after a 29-day FDA review.

K243362 · Cyden Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
29d
Days
Class 2
Risk

K243362 is an FDA 510(k) clearance for the SmoothSkin Pure Switch (SSC1). 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 November 27, 2024 after a review of 29 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 K243362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2024
Decision Date November 27, 2024
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
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
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K243030 · Ulike Co., Ltd. · Oct 2024