ADVANCE-ESTHETIC LLC

FDA Device Registration & Listing · Fort Lauderdale, FL, US · Registration 3013397886

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013397886
FEI Number
3013397886
Entity Name
ADVANCE-ESTHETIC LLC
City/State/Country
Fort Lauderdale, FL, US
Establishment Address
4101 Ravenswood Rd Ste 110, Fort Lauderdale, FL 33312, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Advance-Esthetic LLC (Owner Number: 10053538)
Owner / Operator Contact Address
4101 Ravenswood Rd unit 121-123, Fort Lauderdale, FL 33312, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Zemits Quidion DUO Zemits Quidion Lite Zemits Quidion Zemits Erase ND Zemits PressMio Zemits DioPulse Zemits DetektiLight Zemits Demeter Zemits WaveRestore Zemits LipoPremo Zemits Abigon Zemits ColdRestore Zemits PressMio Zemits EndoLuxx Zemits Bionexis Zemits CelluGlide Zemits Leger Zemits Klein RF Zemits Sisley Zemits CrystalFrax Zemits FrioLift Zemits CelluSpice Zemits AknoEvit Zemits VivoTite Zemits DuoCratus Zemits DuoCratus Pro Zemits CarbonFrax Zemits IPL Light Expert 2 Zemits LumaGenix Zemits Skin Analysis System Zemits VeraFace Zemits LED Zemits YAGenix Zemits LED

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-07-31
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-12-23
KNM Device, Pressure Applying Physical Medicine Class 1 890.5765 2016-12-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-12-23
GMB Light, Wood'S, Fluorescence Microbiology Class 1 866.2600 2022-05-17
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2016-12-14
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2023-07-31
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-07-31
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-02-06
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2016-12-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-02-06
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2024-02-06
HCJ Device, Skin Potential Measurement Neurology Class 2 882.1560 2022-05-17
OLP Over-The-Counter Powered Light Based Laser For Acne General, Plastic Surgery Class 2 878.4810 2022-05-17
OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery Class 2 878.4810 2022-05-17
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-02-06
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2022-05-17

Official Correspondent

Kostiantyn Suichmez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Advance-Esthetic LLC
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
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

Similar Registrations

Registration Number Establishment Name Location
3014980477 ELEMENIC CO., LTD. Seoul, KR
3009462521 Oncore Manufacturing, LLC dba NEOTech Fremont, CA, US
3033905238 BEIJING MEGA BEAUTY TECHNOLOGY CO.,LTD. Beijing, CN
3014384451 LAMEDITECH CO., LTD. Seoul, KR
3010273372 WEIFANG KM ELECTRONICS CO., LTD Weifang Shandong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013397886. Last updated year: 2026. Please use registration number 3013397886 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.