FDA.reportPublic FDA data

Zerona 2.0

Primary DI
00858985006100
Brand
Zerona 2.0
Company
ERCHONIA CORPORATION, LLC
Model
GLS
Catalog number
GLS
Device description
AESTHETIC - Floor Model Low Level Laser -- 6 diodes 532nm 17mW - IFU Reduction Circumference
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLIFat Reducing Low Level Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLIFat Reducing Low Level LaserGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123237000ZERONA 2.0 LASERErchonia Corporation2013-01-25OLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858985006100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858985006100008589850061008589850061000858985006100

GMDN Terms#

Term, Definition table
TermDefinition
Low-intensity laser fat liquefaction systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(888) 242-0571info@erchonia.com

Regulatory Flags#

DUNS number
004053174
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858985006360EVRL-OTCEVRL3-OTC2026-02-09
00858985006292Erchonia Zerona VZ8VZ82025-02-25
00858985006193FX405MLS-AC2020-08-10
00858985006278Erchonia GVLGVL2022-10-31
00858985006186FX635HPS2HPS22020-06-19
00858985006001Base StationBSTBST2016-09-24
00858985006025EVLEVLEVL2016-09-24
00858985006032EVRLEVRLEVRL2016-09-24
00858985006049FX635HPSHPS2016-09-24
00858985006063PL TouchPLTPLT2016-09-24
00858985006087VLSVLSVLS2016-09-24
00858985006094XLR8HLSHLS2016-09-24
00858985006261Erchonia Zerona Z-BedJZB2022-10-31
00858985006155AdjustorVA3VA32020-06-19
00858985006162PercussorVP3VP32020-06-19
00858985006018EmeraldSHLSHL2016-09-24
00858985006124Zerona Z6SHRSHR2016-09-24
00858985006117Zerona ADARCARC2016-09-24
00858985006056LunulaFFSFFS2016-09-24
00858985006070VerjuCLSCLS2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973337180018Led Light Phototherapy BedShenzhen Suyzeko LimitedOLI2026-05-09
06973337180025Led Light Phototherapy BedShenzhen Suyzeko LimitedOLI2026-05-09
00850075326006CellumaBiophotas, Inc.OLI2025-07-24
00850075326044CellumaBiophotas, Inc.OLI2025-07-24
06970006971212EnergyLoungerShenzhen Kaiyan Medical Equipment Co,. LtdOLI2025-06-28
04260489020425R11 Air KBL GmbHOLI2025-06-25
00858985006292Erchonia Zerona VZ8ERCHONIA CORPORATION, LLCOLI2025-02-25
00850523007594CellumaBiophotas, Inc.OLI2024-12-23
00850523007761CellumaBiophotas, Inc.OLI2024-12-23
00850523007891CellumaBiophotas, Inc.OLI2024-12-23
00850523007938CellumaBiophotas, Inc.OLI2024-12-23
00850523007709CellumaBiophotas, Inc.OLI2024-12-20
00858985006261Erchonia Zerona Z-BedERCHONIA CORPORATION, LLCOLI2022-10-31
00860925000338UltraSlim DigitalPHOTONICA USA, LLCOLI2021-01-04
00860925000345UltraSmooth DigitalPHOTONICA USA, LLCOLI2021-01-04
00860925000314CellulizePHOTONICA USA, LLCOLI2020-01-17
00860925000307Photonica ProfessionalPHOTONICA USA, LLCOLI2016-12-21
00086092500307Photonica ProfessionalWARD PHOTONICS LLCOLI2016-12-21
00858985006018EmeraldERCHONIA CORPORATION, LLCOLI2016-09-24
00858985006070VerjuERCHONIA CORPORATION, LLCOLI2016-09-24
00858985006117Zerona ADERCHONIA CORPORATION, LLCOLI2016-09-24
00858985006124Zerona Z6ERCHONIA CORPORATION, LLCOLI2016-09-24