Data / Medical devices / United States / Sharkninja Operating LLC
Sharkninja Operating LLC: FDA-registered device maker in Needham, MA, United States, 1 510(k) clearance
Sharkninja Operating LLC is registered with the FDA (registration 3013738756) in Needham, MA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013738756
- Address
- 89 A St #100, Needham, MA, United States, 02494
- Owner or operator
- SharkNinja Operating LLC (10092175)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 12, 2024
- Registered through
- 2026
- Brand names listed
- ChillPill (UH025), CryoGlow, CryoGlow Plus, Shark Depuffi (FH2XX), Shark FacialPro Glow (FH3XX), Shark FacialPro Glow (FH3XXX)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 27, 2024 | K242796 | CryoGlow (FW3XXXX) | OHS | Substantially Equivalent | Sharkninja Operating, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Pad, Heating, Powered
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
Updated November 27, 2024. 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.