Numiere

Basic Information

• Brand Name: Numiere
• Primary DI: 00850018806701
• Version / Model: 6701
• 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: 708b2dc3-bc7d-42fb-a3ec-b6263899651f

Device Description

Time Keeper Wrinkle Reducing LED Face Mask

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
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66591	Red-light phototherapy unit, home-use	An electrically-powered, patient-worn device designed be used by a layperson in the home (may additionally be used by a healthcare professional in a clinical setting) to emit red light for phototherapy primarily to treat musculoskeletal symptoms (e.g., arthritis pain, spasm, stiffness) and increase muscle relaxation through localized modification of cellular metabolism and/or improvement of blood circulation. It is in the form of a wearable thin adhesive hydrogel patch with integrated light-emitting diodes (LEDs) designed to be applied to the affected area. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850018806701	GS1

Premarket Submissions

Submission Number	Supplement Number
K241857	000