Cleared Traditional

K171702 - Exciplex308nm

K171702 is the FDA 510(k) clearance for Exciplex308nm by Clarteis. It is a Class 2 General & Plastic Surgery device (product code FTC) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K171702 · Clarteis · General & Plastic Surgery device
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Oct 2017
Decision
127d
Days
Class 2
Risk

K171702 is an FDA 510(k) clearance for the Exciplex308nm. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Clarteis (Valbonne, FR). The FDA issued a Cleared decision on October 13, 2017 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4630 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Clarteis devices

Submission Details

510(k) Number K171702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2017
Decision Date October 13, 2017
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTC Light, Ultraviolet, Dermatological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4630
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 - FTC Light, Ultraviolet, Dermatological

All 26
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K171702.
ClearLink Controlled Phototherapy Equipment
K182215 · Daavlin Distributing Company · Oct 2018
308nm Excimer System
K172273 · Chongqing Peninsula Medical Technology Co., Ltd. · Jul 2018
Luma Light System
K173436 · Luma Therapeutics · Jan 2018
CYNOSUREA ECLILITE AND ECLILITE U
K050080 · Cynosure, Inc. · May 2005
BCLEAR
K021762 · Lumenis, Inc. · Aug 2002