Emerald

Basic Information

• Brand Name: Emerald
• Primary DI: 00858985006018
• Version / Model: SHL
• Catalog Number: SHL
• Company Name: ERCHONIA CORPORATION, LLC
• Labeler DUNS: 004053174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2020-01-16
• Public Version Status: Update
• Public Device Record Key: 8f25c868-e0ae-42ab-938e-93511a77a2f3

Device Description

AESTHETIC - Floor Model Low Level Laser -- 10 diodes 532nm 17mW - IFU Reduction BMI +30 or greater

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
OLI	Fat Reducing Low Level Laser	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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858985006018	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]