Home GUDID 00858985006124 Zerona Z6
Primary DI 00858985006124
Brand Zerona Z6
Company ERCHONIA CORPORATION, LLC
Model SHR
Catalog number SHR
Device description AESTHETIC - Floor Model Low Level Laser -- 6 diodes 635nm 17mW - OTC (Non-prescriptive) - IFU Reduction Circumference/Fat
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name OLI Fat Reducing Low Level Laser
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OLI Fat Reducing Low Level Laser General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00858985006124 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00858985006124 00858985006124 858985006124 0858985006124
GMDN Terms# Term, Definition table Term Definition Low-intensity laser fat liquefaction system, mobile 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.
Regulatory Flags# DUNS number 004053174 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00858985006391 Erchonia CLX ERCHONIA CORPORATION, LLC OLI 2026-07-21 06973337180018 Led Light Phototherapy Bed Shenzhen Suyzeko Limited OLI 2026-05-09 06973337180025 Led Light Phototherapy Bed Shenzhen Suyzeko Limited OLI 2026-05-09 00850075326006 Celluma Biophotas, Inc. OLI 2025-07-24 00850075326044 Celluma Biophotas, Inc. OLI 2025-07-24 06970006971212 EnergyLounger Shenzhen Kaiyan Medical Equipment Co,. Ltd OLI 2025-06-28 04260489020425 R11 Air KBL GmbH OLI 2025-06-25 00858985006292 Erchonia Zerona VZ8 ERCHONIA CORPORATION, LLC OLI 2025-02-25 00850523007594 Celluma Biophotas, Inc. OLI 2024-12-23 00850523007761 Celluma Biophotas, Inc. OLI 2024-12-23 00850523007891 Celluma Biophotas, Inc. OLI 2024-12-23 00850523007938 Celluma Biophotas, Inc. OLI 2024-12-23 00850523007709 Celluma Biophotas, Inc. OLI 2024-12-20 00858985006261 Erchonia Zerona Z-Bed ERCHONIA CORPORATION, LLC OLI 2022-10-31 00860925000338 UltraSlim Digital PHOTONICA USA, LLC OLI 2021-01-04 00860925000345 UltraSmooth Digital PHOTONICA USA, LLC OLI 2021-01-04 00860925000314 Cellulize PHOTONICA USA, LLC OLI 2020-01-17 00860925000307 Photonica Professional PHOTONICA USA, LLC OLI 2016-12-21 00086092500307 Photonica Professional WARD PHOTONICS LLC OLI 2016-12-21 00858985006018 Emerald ERCHONIA CORPORATION, LLC OLI 2016-09-24 00858985006070 Verju ERCHONIA CORPORATION, LLC OLI 2016-09-24 00858985006100 Zerona 2.0 ERCHONIA CORPORATION, LLC OLI 2016-09-24 00858985006117 Zerona AD ERCHONIA CORPORATION, LLC OLI 2016-09-24
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