PelleFirm 30MM HP, 3-pack

Basic Information

• Brand Name: PelleFirm 30MM HP, 3-pack
• Primary DI: 00841494108243
• Version / Model: P330PFHPU
• Company Name: Cynosure, LLC
• Labeler DUNS: 780318028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-17
• Public Version: 2
• Public Version Date: 2023-01-11
• Public Version Status: Update
• Public Device Record Key: 73c4335c-35b6-420d-ba3a-29b9c55f8d86

Device Description

PelleFirm 30MM HP, 3-pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• 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
45214	Radio-frequency skin contouring system applicator, monopolar	A monopolar handpiece that is part of a skin contouring system that uses radio-frequency (RF) energy to provide a capacitively coupled electrical connection for the transfer of radiated energy through a patient's skin in deep heat-mediated skin modification. The current passes from this device to an indifferent return electrode placed on the patient. This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841494108243	GS1

Premarket Submissions

Submission Number	Supplement Number
K132949	000