Data / Medical devices / United States / Glownar Aesthetics. LLC
Glownar Aesthetics. LLC: FDA-registered device maker in Davie, FL, United States, 8 510(k) clearances
Glownar Aesthetics. LLC is registered with the FDA (registration 3022327202) in Davie, FL, United States. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022327202
- Address
- 11850 W State Road 84 Ste 1a, Davie, FL, United States, 33325
- Owner or operator
- Glownar Aesthetics. LLC (10095419)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 13, 2026
- Registered through
- 2026
- Brand names listed
- Goldskin Elite Radiofrequency Microneedling & Fractional RF, Hydro Soline, Hydroglow, Purehydro, Truhydro, Hydro Oxylune, Hydro Crown, Bellezza, Brilliance Diamond, Gem Diamond, Plasmoderm X Fractional & Cold Plasma, Revita Ink Remaster Tattoo Removal & Skin Rejuvenation, Silk Lotus CO2 Laser, The Medi Next Advanced IPL Hair Removal and Skin Rejuvenation, The Veloce Diode 3 Laser Hair Removal, Torno Diode Laser Hair Removal with 4 wavelengths and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Complaint file establishment | accessdata.fda.gov |
| Low Power Electrosurgical Devices For Skin Lesion Destruction | QVJ | 2 | Complaint file establishment | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Microneedle Device | QAI | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| June 9, 2025 | K250830 | LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) | OHS | Substantially Equivalent | Shenzhen Sungrow Led Technology Co., Ltd. | accessdata.fda.gov |
| January 27, 2025 | K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1) | GEX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| February 20, 2024 | K233760 | Mjolnir Pro. (Multielectrode plasma) | QVJ | Substantially Equivalent | Shenzhen Leaflife Technology Co., Ltd. | accessdata.fda.gov |
| November 2, 2023 | K232532 | Nd:Yag Laser Therapy Systems | GEX | Substantially Equivalent | Beijing Unt Technology 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 |
| August 11, 2023 | K230420 | Dr. pen Microneedling System | QAI | Substantially Equivalent | Guangzhou Ekai Electronic Technology Co., Ltd. | accessdata.fda.gov |
| April 6, 2020 | K191970 | Diode Laser Hair Removal System | GEX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| February 11, 2013 | K123435 | IPL THERAPY SYSTEM | ONF | Substantially Equivalent | Beijing Sincoheren S&T Development Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Powered Microneedle Device
Updated June 9, 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.