Data / Medical devices / United States / Arca Aesthetics, LLC
Arca Aesthetics, LLC: FDA-registered device maker in Long Beach, NY, United States, 2 510(k) clearances
Arca Aesthetics, LLC is registered with the FDA (registration 3041918479) in Long Beach, NY, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 9, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3041918479
- Address
- 120 W Park Ave Ste 312b, Long Beach, NY, United States, 11561
- Owner or operator
- Arca Aesthetics, LLC (10094173)
- Roles
- Complaint file establishment
- First device listed
- August 11, 2026
- Registered through
- 2027
- Brand names listed
- Luxa CO2, illumeaRF
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 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 | K250465 | CO2 Laser Machine (Lume) | GEX | Substantially Equivalent | Nanjing Bestview Laser S&T 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 |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Powered Laser Surgical Instrument
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.