Numiere

Basic Information

• Brand Name: Numiere
• Primary DI: 00850018806664
• Version / Model: 6664
• Company Name: Heatinaclick LLC
• Labeler DUNS: 043038693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-31
• Public Version: 1
• Public Version Date: 2025-02-10
• Public Version Status: New
• Public Device Record Key: e618bc93-d741-4dcb-94e5-5e6852a7ecb9

Device Description

Numiere Body - Cellulite Reducing, Body Toning & Skin Tightening

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66988	Home-use radio-frequency skin contouring unit	A device intended to be used by a layperson in the home to apply radio-frequency energy heat to subdermal tissues for reduction of facial wrinkles and cosmetic rejuvenation. It consists of an electrically-powered portable unit designed to be hand-held against the face in circular motions whereby the transcutaneously applied heat induces collagen fibre regeneration and improves skin tightening.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850018806664	GS1

Premarket Submissions

Submission Number	Supplement Number
K214015	000