Cleared Special

K233782 - SmoothSkin Pure Adapt (SSG3)

K233782 is the FDA 510(k) clearance for SmoothSkin Pure Adapt (SSG3) by Cyden Limited. It is a Class 2 General & Plastic Surgery device (product code OHT) cleared through the Special 510(k) pathway after a 23-day FDA review.

K233782 · Cyden Limited · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2023
Decision
23d
Days
Class 2
Risk

K233782 is an FDA 510(k) clearance for the SmoothSkin Pure Adapt (SSG3). 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 December 20, 2023 after a review of 23 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 K233782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2023
Decision Date December 20, 2023
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 K233782.
IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)
K233887 · Shenzhen Ulike Smart Electronics Co., Ltd. · Jan 2024
IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,)
K233664 · Shenzhen Ulike Smart Electronics Co., Ltd. · Jan 2024
IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)
K233679 · Shenzhen Ulike Smart Electronics Co., Ltd. · Jan 2024
IPL Hair Removal Device
K232939 · Shenzhen Borria Technology Co., Ltd. · Dec 2023
Light Based Hair Removal Device
K232846 · Shenzhen Meik Beauty Industry Co., Ltd. · Dec 2023
Intense Pulse Light Therapeutic Apparatus
K232932 · Shenzhen Greatro Electronic Technology Co., Ltd. · Dec 2023