XLR8 HLS

GUDID 00858985006094

MEDICAL - Handheld Low Level Laser - 2 diodes - 640nm 10mW - includes induction charger

ERCHONIA CORPORATION, LLC

Musculoskeletal/physical therapy laser, professional
Primary Device ID00858985006094
NIH Device Record Key35cda0d8-305f-46fc-8697-ffab5d1bad2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameXLR8
Version Model NumberHLS
Catalog NumberHLS
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
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858985006094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHNPowered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-07
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

Trademark Results [XLR8]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XLR8
XLR8
97574700 not registered Live/Pending
Petra Automotive Products, Inc.
2022-09-01
XLR8
XLR8
90900617 not registered Live/Pending
24 Hour Fitness USA, LLC
2021-08-24
XLR8
XLR8
90511424 not registered Live/Pending
Kent Precision Foods Group, Inc.
2021-02-04
XLR8
XLR8
90511319 not registered Live/Pending
Kent Precision Foods Group, Inc.
2021-02-04
XLR8
XLR8
88775387 not registered Live/Pending
Hitting Store, LLC
2020-01-28
XLR8
XLR8
88396331 not registered Live/Pending
PROSPERITY HOME MORTGAGE, LLC
2019-04-22
XLR8
XLR8
88185420 not registered Dead/Abandoned
VRM International Pty Ltd
2018-11-07
XLR8
XLR8
88180921 not registered Live/Pending
Price, Jacob Sidney
2018-11-04
XLR8
XLR8
88097915 not registered Dead/Abandoned
GENADYNE BIOTECHNOLOGIES, INC.
2018-08-29
XLR8
XLR8
88080576 not registered Live/Pending
PNY Technologies, Inc.
2018-08-16
XLR8
XLR8
88080570 not registered Live/Pending
PNY Technologies, Inc.
2018-08-16
XLR8
XLR8
87530237 5473626 Live/Registered
Excelerate, LLC
2017-07-17

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