Data / Medical devices / United States / Hermanator8, LLC
Hermanator8, LLC: FDA-registered device maker in Canton, GA, United States, 1 510(k) clearance
Hermanator8, LLC is registered with the FDA (registration 3044519321) in Canton, GA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044519321
- Address
- 1987 Batesville Rd, Canton, GA, United States, 30115
- Owner or operator
- Hermanator8, LLC (10095737)
- Roles
- Repackager or relabeler
- First device listed
- April 21, 2026
- Registered through
- 2026
- Brand names listed
- Visnova Laser 4, Visnova Shockwave Therapy (Model VS1), HyrdroWave 2 (Model HW2)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Repackager or relabeler | 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 19, 2025 | K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | ILY | Substantially Equivalent | Gigaalaser Company , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Updated May 19, 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.