Data / Medical devices / United States / Alc Enterprises Inc
Alc Enterprises Inc: FDA-registered device maker in Brooklyn, NY, United States, 7 510(k) clearances
Alc Enterprises Inc is registered with the FDA (registration 3011721071) in Brooklyn, NY, United States. It lists 12 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 23, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011721071
- Address
- 134 Stockton Street 1C, Brooklyn, NY, United States, 11206
- Owner or operator
- Aura Medical LLC (10049729)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- July 27, 2017
- Registered through
- 2027
- Brand names listed
- Caring Mill By Aura Serene, GLIDE ON GEL, Glide Facial Therapy Device, Illumine Scaler, Jumper Pulse Oximeter
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 |
|---|---|---|---|---|---|---|
| December 23, 2025 | K252187 | Aura Glide (FC40) | NFO | Substantially Equivalent | Aura Medical, LLC | accessdata.fda.gov |
| December 13, 2022 | K222770 | Conductive Gel | GYB | Substantially Equivalent | Top-Rank Health Care Co., Ltd. | accessdata.fda.gov |
| June 25, 2020 | K193348 | Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Viatom Technology Co., Ltd. | accessdata.fda.gov |
| December 18, 2019 | K191667 | Electronic Stethoscope | DQD | Substantially Equivalent | Hefei Mintti Medical Technology Co., Ltd. China | accessdata.fda.gov |
| December 2, 2019 | K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) | NUH | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| August 28, 2014 | K140582 | FINGERTIP PULSE OXIMETER | DQA | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
| May 30, 2014 | K140211 | ULTRASONIC MESH NEBULIZER | CAF | Substantially Equivalent | Foshan Gaunying Electronics Co., Ltd. | accessdata.fda.gov |
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Updated December 23, 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.