Cleared Special

K124042 - TANDA MINI SKINCARE SYSTEM (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K124042 · Syneron Beauty · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
95d
Days
Class 2
Risk

K124042 is an FDA 510(k) clearance for the TANDA MINI SKINCARE SYSTEM. Classified as Over-the-counter Powered Light Based Laser For Acne (product code OLP), Class II - Special Controls.

Submitted by Syneron Beauty (Philedelphia, US). The FDA issued a Cleared decision on April 2, 2013 after a review of 95 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Syneron Beauty devices

Submission Details

510(k) Number K124042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2012
Decision Date April 02, 2013
Days to Decision 95 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 115d · This submission: 95d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OLP Over-the-counter Powered Light Based Laser For Acne
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris.
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 - OLP Over-the-counter Powered Light Based Laser For Acne

All 50
Devices cleared under the same product code (OLP) and FDA review panel - the closest regulatory comparables to K124042.
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
K253878 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Mar 2026
Erchonia EVRL
K251843 · Erchonia Corporation · Sep 2025
LED Light Therapy Mask (RT01)
K242068 · Ningbo Dechang Electrical Machinery Made Co.,Ltd · Apr 2025
LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
K243555 · Shenzhen Eyco Technology Co., Ltd. · Feb 2025
BLU TOTALE (Model: ENEOB852)
K232656 · Premier North America, Inc. · Nov 2023
PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
K230490 · Dongguan Hunter Electronic Technology Co., Ltd. · Oct 2023