Data / Medical devices / United States / Estetique Inc. Usa
Estetique Inc. Usa: FDA-registered device maker in Weston, FL, United States, 4 510(k) clearances
Estetique Inc. Usa is registered with the FDA (registration 3003015433) in Weston, FL, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 20, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003015433
- Address
- 2145 N Commerce Parkway, Weston, FL, United States, 33326
- Owner or operator
- Estetique Inc. USA (10037089)
- Roles
- Repackager or relabeler
- First device listed
- June 16, 2011
- Registered through
- 2026
- Brand names listed
- DermaMax, DermaMax RF, Estetique Cellulite System, LipoMax RF, LipoMax RF 360, LipoMax RF Face Body, LipoMax Sculpt, LumiMax and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Manual | GED | 1 | Repackager or relabeler | accessdata.fda.gov |
| Brush, Dermabrasion, Powered | GFE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Massager, Vacuum, Light Induced Heating | NUV | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| December 20, 2019 | K192755 | Soli-Lite LG4 Galileo | GEX | Substantially Equivalent | Silhouet-Tone Corporation | accessdata.fda.gov |
| November 24, 2009 | K083123 | MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES | GEX | Substantially Equivalent | Medart A/S | accessdata.fda.gov |
| July 1, 2009 | K090221 | REACTION SYSTEM | NUV | Substantially Equivalent | Viora , Ltd. | accessdata.fda.gov |
| February 6, 2009 | K082825 | ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM | GEX | Substantially Equivalent | Energist, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Brush, Dermabrasion, Manual
- All makers of Powered Laser Surgical Instrument
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Massager, Therapeutic, Electric
- All makers of Brush, Dermabrasion, Powered
- All makers of Massager, Vacuum, Light Induced Heating
Updated December 20, 2019. 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.