Data / Medical devices / United States / World Aesthetix LLC
World Aesthetix LLC: FDA-registered device maker in Jacksonville, FL, United States, 6 510(k) clearances
World Aesthetix LLC is registered with the FDA (registration 3025104654) in Jacksonville, FL, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025104654
- Address
- 3740 Saint Johns Bluff Rd S Ste 8, Jacksonville, FL, United States, 32224
- Owner or operator
- WORLD AESTHETIX LLC (10090419)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 23, 2024
- Registered through
- 2026
- Brand names listed
- NuShine LED Skin Therapy, nuCORE 8:1, nuFIRM, nuFORM 16e, nuGLOW PICO PLUS, nuSILK AI Diode
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Massager, Vacuum, Light Induced Heating | NUV | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 20, 2024 | K240474 | Multi-function Platform Systems (BL-M10) | GEX | Substantially Equivalent | Shanghai Bele Medical Technology Co.,Ltd | accessdata.fda.gov |
| May 16, 2024 | K240386 | Picosecond Nd:YAG Laser Systems (BL-C10) | GEX | Substantially Equivalent | Shanghai Bele Medical Technology Co.,Ltd | accessdata.fda.gov |
| September 20, 2023 | K231894 | LED Spectrum therapy instrument | GEX | Substantially Equivalent | Shenzhenshi Sincoheren S&T Development Co., Ltd. | accessdata.fda.gov |
| March 29, 2020 | K192039 | Torc Body | NGX | Substantially Equivalent | Johari Digital Healthcare Limited | accessdata.fda.gov |
| April 17, 2018 | K180353 | Diode laser hair removal device | GEX | Substantially Equivalent | Zhengzhou PZ Laser Slim Technology Co., Ltd. | accessdata.fda.gov |
| March 2, 2017 | K161892 | Slimming Treatment Device | NUV | Substantially Equivalent | Beijing Honkon Technologies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Powered Laser Surgical Instrument
- All makers of Massager, Therapeutic, Electric
- All makers of Massager, Vacuum, Light Induced Heating
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Updated May 20, 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.