Erchonia CLX

Primary DI
00858985006391
Brand
Erchonia CLX
Company
ERCHONIA CORPORATION, LLC
Model
CFL
Catalog number
CFL
Device description
AESTHETIC - Handheld Low Level Laser - 2 diodes 520nm & 405 nm 7.5 mW - includes induction charger - IFU dermatological aesthetic treatment for improving the appearance of submental fat
Published
2026-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K252574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252574000Erchonia CLX (Model # CFL)Erchonia Corporation2025-12-15OLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858985006391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858985006391008589850063918589850063910858985006391

GMDN Terms#

Term, Definition table
TermDefinition
Low-intensity laser fat liquefaction system, hand-heldA device designed to be used 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 applications [e.g., body contouring, circumference reduction, lipid reduction]. It consists of a battery-powered hand-held unit with an application endpiece through which the laser energy is delivered to the target site (e.g., chin).

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858985006292Erchonia Zerona VZ8VZ82025-02-25
00858985006261Erchonia Zerona Z-BedJZB2022-10-31
00858985006018EmeraldSHLSHL2016-09-24
00858985006070VerjuCLSCLS2016-09-24
00858985006100Zerona 2.0GLSGLS2016-09-24
00858985006117Zerona ADARCARC2016-09-24
00858985006124Zerona Z6SHRSHR2016-09-24
00858985006032EVRLEVRLEVRL2016-09-24
00858985006360EVRL-OTCEVRL3-OTC2026-02-09
00858985006193FX405MLS-AC2020-08-10
00858985006278Erchonia GVLGVL2022-10-31
00858985006186FX635HPS2HPS22020-06-19
00858985006001Base StationBSTBST2016-09-24
00858985006025EVLEVLEVL2016-09-24
00858985006049FX635HPSHPS2016-09-24
00858985006063PL TouchPLTPLT2016-09-24
00858985006087VLSVLSVLS2016-09-24
00858985006094XLR8HLSHLS2016-09-24
00858985006155AdjustorVA3VA32020-06-19
00858985006162PercussorVP3VP32020-06-19

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Primary DI, Brand, Company table
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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
00858985006100Zerona 2.0ERCHONIA CORPORATION, LLCOLI2016-09-24
00858985006117Zerona ADERCHONIA CORPORATION, LLCOLI2016-09-24
00858985006124Zerona Z6ERCHONIA CORPORATION, LLCOLI2016-09-24