Venus Bliss

Basic Information

• Brand Name: Venus Bliss
• Primary DI: 00810060830444
• Version / Model: BL000001
• Company Name: Venus Concept Inc.
• Labeler DUNS: 117333774
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-08
• Public Version: 1
• Public Version Date: 2023-06-16
• Public Version Status: New
• Public Device Record Key: c8f2432b-b3fd-4e2b-a86f-024b98062394

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: Yes
• Has Lot/Batch Number: No
• 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
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	General, Plastic Surgery	878.5400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58252	Low-intensity laser fat liquefaction system	An assembly of devices designed for the noninvasive application of low-level laser energy [low-level laser therapy (LLLT)] to liquefy (emulsify) subcutaneous and visceral adipose tissue (fat) for cosmetic/aesthetic (e.g., body contouring, circumference reduction) and medical (e.g. weight-loss, lipid reduction) applications. It is a mains electricity (AC-powered) system, mobile on wheels, which incorporates laser diode modules on adjustable arms, a control monitor, and software. It is an independent, primary device which may be used as an adjunct modality in conjunction with liposuction and surgical techniques as a secondary function.	No	Active
45219	Radio-frequency skin contouring system	An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810060830444	GS1

Premarket Submissions

Submission Number	Supplement Number
K190743	000