Data / Medical devices / United States / Advance-Esthetic LLC
Advance-Esthetic LLC: FDA-registered device maker in Fort Lauderdale, FL, United States, 14 510(k) clearances
Advance-Esthetic LLC is registered with the FDA (registration 3013397886) in Fort Lauderdale, FL, United States. It lists 11 device types. The FDA files 14 510(k) clearances under its listings, the newest dated February 5, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013397886
- Address
- 4101 Ravenswood Rd Ste 110, Fort Lauderdale, FL, United States, 33312
- Owner or operator
- Advance-Esthetic LLC (10053538)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- December 14, 2016
- Registered through
- 2027
- Brand names listed
- HydroDiamond Facial Platform, VivaFacial Platform, Zemits Abigon, Zemits Adrinox 2, Zemits AknoEvit, Zemits Bionexis, Zemits CarbonFrax, Zemits CarbonFrax Pro and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| February 5, 2025 | K243555 | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) | OLP | Substantially Equivalent | Shenzhen Eyco Technology Co., Ltd. | accessdata.fda.gov |
| January 28, 2025 | K243423 | LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) | OHS | Substantially Equivalent | Shenzhen Rainbow Technology Co., Ltd. | accessdata.fda.gov |
| December 20, 2024 | K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) | GEX | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| March 15, 2024 | K233307 | Intensity Pulsed Light Therapy System | ONF | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| February 20, 2024 | K231896 | Diode Laser Therapy System | GEX | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| October 19, 2023 | K231749 | Radio Frequency System | GEI | Substantially Equivalent | Shenzhenshi Sincoheren S&T Development Co., Ltd. | accessdata.fda.gov |
| November 10, 2021 | K212978 | Diode laser therapy system | GEX | Substantially Equivalent | Beijing Unt Technology Co., Ltd. | accessdata.fda.gov |
| October 22, 2021 | K211735 | CO2 Laser Machine, Model: BW-203B | GEX | Substantially Equivalent | Zhengzhou Bestview ST Co., Ltd. | accessdata.fda.gov |
| November 16, 2020 | K202758 | Nd: YAG Laser Therapy Systems HM-YL900 | GEX | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| June 24, 2020 | K193477 | Nd: YAG Laser Therapy Systems | GEX | Substantially Equivalent | Beijing Kes Biology Technology Co., Ltd. | accessdata.fda.gov |
| May 21, 2020 | K200751 | Photodynamic Therapy (PDT) Equipment | GEX | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| March 25, 2020 | K193328 | IPL + Diode Laser Machine | ONF | Substantially Equivalent | Beijing Globalipl Development Co., Ltd. | accessdata.fda.gov |
| January 30, 2017 | K162098 | LED Phototherapy Device | OLP | Substantially Equivalent | Li-Tek Electronic Technology Corporation | accessdata.fda.gov |
| January 22, 2013 | K122995 | INTENSE PULSED LIGHT (IPL) SYSTEMS | ONF | Substantially Equivalent | Beijing Kes Biology Technology Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 9, 2023 | 93194 | Class II | Ongoing | MED-810A Zemits NDPrime Laser products | Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standards and certification. This Recall provides correction by the firm regarding Zemits NdPrime Yag Tattoo Removal Laser. The product requires update or is missing the following | accessdata.fda.gov |
Compare with other makers
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Light, Wood'S, Fluorescence
- All makers of Powered Laser Surgical Instrument
- All makers of Device, Skin Potential Measurement
Updated February 5, 2025. 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.