Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013576619

FEI Number

3013576619

Entity Name

Aesthetic experts labs ltd

City/State/Country

Cork Dublin, IE

Establishment Address

1st Floor, 2 Penrose Dock, Victorian Quarter, Cork Dublin T23 YY09, IE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Aesthetic expert laboratory (Owner Number: 10055014)

Owner / Operator Contact Address

2121 SW 3rd Avenue, Suite 500, SUITE 500, Miami, FL 33129, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DERMASCULPT EZSYRINGE; EZSYRINGE BLUE; EZSYRINGE RED; EZSYRINGE WHITE EZINJECT EZCONNECTOR & EZSYRINGE CONNECTOR &EZHOLDER &EZSYRINGE ADAPTOR ezPRF ezGEL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-07-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-04-18
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2020-11-10
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2019-12-24
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2022-04-18
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2017-05-24

Official Correspondent

LUC DEWANDRE

US Agent Details

Yasmine Kerdoudi Email: yasmine@ae.expert Phone: (305) 5380110

Related Public Records

Same Entity

Aesthetic expert laboratory

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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3023138850	AQ THERAPEUTICS, INC.	Irvine, CA, US
1526439	DEPUY SPINE, INC.	RAYNHAM, MA, US
1058584	Sterigenics US LLC	Charlotte, NC, US
1221763	ARCH Medical Solutions - Seabrook	SEABROOK, NH, US
8043496	REDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013576619. Last updated year: 2026. Please use registration number 3013576619 when referencing this establishment in official correspondence.