Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007554929

FEI Number

3007554929

Entity Name

PREMIER DEAD SEA COSMETIC LABORATORIES LTD

City/State/Country

Shoham Central, IL

Establishment Address

21 Hashaked St. Shoham Industry Park, Shoham Central 6085001, IL

Establishment Type(s)

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

Owner / Operator

Premier Dead Sea Cosmetic Laboratories Ltd (Owner Number: 10058378)

Owner / Operator Contact Address

21 Hashaked St. Shoham Industry Park, Shoham, IL-M 6085001, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213841

PMA Number

N/A

All Registered Proprietary Names

BLU TOTALE Avologi ENEO NUNA MAX NUNA PRO NUNA TELOSIN V

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2024-03-14
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2018-09-07
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2024-03-14
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2022-04-13

Official Correspondent

Yaneev Yuval

US Agent Details

Ellis Tamari Business: PREMIER NORTH AMERICA, INC Email: premiershai@premierna.com Phone: (404) 4928133

Related Public Records

Same Entity

Premier Dead Sea Cosmetic Laboratories Ltd

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007554929. Last updated year: 2026. Please use registration number 3007554929 when referencing this establishment in official correspondence.