Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014226003

FEI Number

3014226003

Entity Name

CLARTEIS

City/State/Country

Vallauris Alpes-Maritimes, FR

Establishment Address

2791 chemin Saint Bernard, Bat A, Vallauris Alpes-Maritimes 06220, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CLARTEIS (Owner Number: 10056967)

Owner / Operator Contact Address

WTC2, 120 route des macarons, Valbonne, FR-06 06560, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171702

PMA Number

N/A

All Registered Proprietary Names

Exci308 Exciplex Exci308 by aerolase Exciplex 308nm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTC	Light, Ultraviolet, Dermatological	General, Plastic Surgery	Class 2	878.4630	2021-10-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-02-05
FTC	Light, Ultraviolet, Dermatological	General, Plastic Surgery	Class 2	878.4630	2018-02-05

Official Correspondent

Laurent MEILHAC

US Agent Details

Alexia Haralambous Business: RQM+ Email: AHaralambous@rqmplus.com Phone: (267) 7785114

Related Public Records

Same Entity

CLARTEIS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K800950	Tanit, Inc.	TANIT HOME SUNTANNING UNIT	1980-06-04
K230382	Daavlin Distributing Co.	3 Series NeoLux	2023-03-24
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

Similar Registrations

Registration Number	Establishment Name	Location
3023306694	SHANGHAI SIGMA HIGH-TECH CO., LTD.	Shanghai, CN
3002672225	SPECTRUM ASSEMBLY INC.	Carlsbad, CA, US
9680413	ULTRASUN	HENGELO Overijssel, NL
1526255	THE DAAVLIN DISTRIBUTING CO.	Bryan, OH, US
3004167969	ALMA LASERS LTD.	CAESAREA Northern, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014226003. Last updated year: 2026. Please use registration number 3014226003 when referencing this establishment in official correspondence.