Data / Medical devices / United States / Healthlight LLC
Healthlight LLC: FDA-registered device maker in Jupiter, FL, United States, 2 510(k) clearances
Healthlight LLC is registered with the FDA (registration 3012482375) in Jupiter, FL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 13, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012482375
- Address
- 110 Front Street Suite 300, Jupiter, FL, United States, 33477
- Owner or operator
- HealthLight LLC (10048439)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 14, 2015
- Registered through
- 2026
- Brand names listed
- Model BT-132-S Medium Pad System (Brain Tap), Model BT-HB-S Headband System (BrainTap), Model HL-132-S Medium Pad System, Model HL-180-S Painbuster II System, Model HL-264-S Large Pad System, Model HL-90-S Painbuster System, Model HL-CP-S, Foot and Hand Pad System, Model HL-FB-V1 FootBed V.1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment, Manufacturer | 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 13, 2017 | K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System | ILY | Substantially Equivalent | Healthlight, LLC | accessdata.fda.gov |
| January 21, 2011 | K101894 | HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT | ILY | Substantially Equivalent | Bioremedi Therapeutic Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 13, 2017. 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.