SHARKNINJA OPERATING LLC

FDA Device Registration & Listing · Needham, MA, US · Registration 3013738756

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013738756
FEI Number
3013738756
Entity Name
SHARKNINJA OPERATING LLC
City/State/Country
Needham, MA, US
Establishment Address
89 A St #100, Needham, MA 02494, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
SharkNinja Operating LLC (Owner Number: 10092175)
Owner / Operator Contact Address
89 A St #100, Needham, MA 02494, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CryoGlow ChillPill (UH025) Shark FacialPro Glow (FH3XXX) Shark Depuffi (FH2XX) Shark FacialPro Glow (FH3XX)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLP Over-The-Counter Powered Light Based Laser For Acne General, Plastic Surgery Class 2 878.4810 2024-12-12
OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery Class 2 878.4810 2024-12-12
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2025-08-14
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2025-07-07

Official Correspondent

Adam Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SharkNinja Operating LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K881862 Thermo Body Wrap Systems, Inc. THERMO-BODY-WRAP SYSTEM 1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013738756. Last updated year: 2026. Please use registration number 3013738756 when referencing this establishment in official correspondence.
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