Zerona 2.0 GLS

GUDID 00858985006100

AESTHETIC - Floor Model Low Level Laser -- 6 diodes 532nm 17mW - IFU Reduction Circumference

ERCHONIA CORPORATION, LLC

Low-intensity laser fat liquefaction system
Primary Device ID00858985006100
NIH Device Record Key28194bb8-584a-4a59-b74d-dcf9de97b5cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameZerona 2.0
Version Model NumberGLS
Catalog NumberGLS
Company DUNS004053174
Company NameERCHONIA CORPORATION, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(888) 242-0571
Emailinfo@erchonia.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858985006100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLIFat Reducing Low Level Laser

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by ERCHONIA CORPORATION, LLC

00858985006261 - Erchonia Zerona Z-Bed2022-11-08 AESTHETIC - Floor Model Low Level Laser -- 12 diodes 640nm 17mW - OTC (Non-prescriptive) - IFU Reduction Circumference
00858985006278 - Erchonia GVL2022-11-08 MEDICAL - Handheld Low Level Laser - 2 diodes 520nm & 405 nm 7.5 mW - includes induction charger - IFU Reduction Pain, and treat
00858985006193 - FX4052020-08-18 MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - 1 diode 23mW 405nm - IFU Pain Reduction, Acne Reduction
00858985006155 - Adjustor2020-06-29 THERAPEUTIC – Handheld Variable Adjuster – IFU adjunctive use for treatment of symptoms associate with pain
00858985006162 - Percussor2020-06-29 THERAPEUTIC – Handheld Galvanic Massager – IFU temporary reduction of the appearance of cellulite
00858985006186 - FX6352020-06-29 MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Pain Reduction
00858985006018 - Emerald2020-01-16 AESTHETIC - Floor Model Low Level Laser -- 10 diodes 532nm 17mW - IFU Reduction BMI +30 or greater
00858985006049 - FX6352019-09-09 MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Reduction of Musculoskeletal Pain

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