Data / Medical devices / Israel / Premier Dead Sea Cosmetic Laboratories Ltd
Premier Dead Sea Cosmetic Laboratories Ltd: FDA-registered device maker in Shoham Central, Israel, 5 510(k) clearances
Premier Dead Sea Cosmetic Laboratories Ltd is registered with the FDA (registration 3007554929) in Shoham Central, Israel. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 1, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007554929
- Address
- 21 Hashaked St. Shoham Industry Park, Shoham Central, Israel, 6085001
- Owner or operator
- Premier Dead Sea Cosmetic Laboratories Ltd (10058378)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- September 7, 2018
- Registered through
- 2026
- Brand names listed
- Avologi ENEO, BLU TOTALE, NUNA, NUNA MAX, NUNA PRO, TELOSIN V
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 1, 2024 | K233862 | NUNA LUX (NUNL528) | OHS | Substantially Equivalent | Premier North America, Inc. | accessdata.fda.gov |
| November 14, 2023 | K232656 | BLU TOTALE (Model: ENEOB852) | OLP | Substantially Equivalent | Premier North America, Inc. | accessdata.fda.gov |
| February 24, 2022 | K214100 | Luminice | NFO | Substantially Equivalent | Premier North America, Inc. | accessdata.fda.gov |
| January 6, 2022 | K213841 | ENEO TOTALE (Model: ENEOT947) | OHS | Substantially Equivalent | Premier North America, Inc. | accessdata.fda.gov |
| July 26, 2018 | K181659 | Avologi ENEO | OHS | Substantially Equivalent | Premier North America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
Updated March 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.