Exciplex

Light, Ultraviolet, Dermatological

Clarteis

The following data is part of a premarket notification filed by Clarteis with the FDA for Exciplex.

Pre-market Notification Details

Device IDK191086
510k NumberK191086
Device Name:Exciplex
ClassificationLight, Ultraviolet, Dermatological
Applicant Clarteis WTC2, 120 Route Des Macarons Valbonne,  FR 06560
ContactLaurent Meilhac
CorrespondentLucie Dalet
Acknowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego,  CA  92110
Product CodeFTC  
CFR Regulation Number878.4630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-24
Decision Date2019-12-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03760313461017 K191086 000

Trademark Results [Exciplex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXCIPLEX
EXCIPLEX
79205928 5420470 Live/Registered
Clarteis
2017-02-01

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