XLR8 HLS
GUDID 00858985006094
MEDICAL - Handheld Low Level Laser - 2 diodes - 640nm 10mW - includes induction charger
ERCHONIA CORPORATION, LLC
Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional| Primary Device ID | 00858985006094 |
| NIH Device Record Key | 35cda0d8-305f-46fc-8697-ffab5d1bad2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XLR8 |
| Version Model Number | HLS |
| Catalog Number | HLS |
| Company DUNS | 004053174 |
| Company Name | ERCHONIA CORPORATION, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858985006094 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| NHN | Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-05-07 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by ERCHONIA CORPORATION, LLC
| 00858985006261 - Erchonia Zerona Z-Bed | 2022-11-08 AESTHETIC - Floor Model Low Level Laser -- 12 diodes 640nm 17mW - OTC (Non-prescriptive) - IFU Reduction Circumference |
| 00858985006278 - Erchonia GVL | 2022-11-08 MEDICAL - Handheld Low Level Laser - 2 diodes 520nm & 405 nm 7.5 mW - includes induction charger - IFU Reduction Pain, and treat |
| 00858985006193 - FX405 | 2020-08-18 MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - 1 diode 23mW 405nm - IFU Pain Reduction, Acne Reduction |
| 00858985006155 - Adjustor | 2020-06-29 THERAPEUTIC – Handheld Variable Adjuster – IFU adjunctive use for treatment of symptoms associate with pain |
| 00858985006162 - Percussor | 2020-06-29 THERAPEUTIC – Handheld Galvanic Massager – IFU temporary reduction of the appearance of cellulite |
| 00858985006186 - FX635 | 2020-06-29 MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Pain Reduction |
| 00858985006018 - Emerald | 2020-01-16 AESTHETIC - Floor Model Low Level Laser -- 10 diodes 532nm 17mW - IFU Reduction BMI +30 or greater |
| 00858985006049 - FX635 | 2019-09-09 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 97574700 not registered Live/Pending |
Petra Automotive Products, Inc. 2022-09-01 |
 XLR8 90900617 not registered Live/Pending |
24 Hour Fitness USA, LLC 2021-08-24 |
 XLR8 90511424 not registered Live/Pending |
Kent Precision Foods Group, Inc. 2021-02-04 |
 XLR8 90511319 not registered Live/Pending |
Kent Precision Foods Group, Inc. 2021-02-04 |
 XLR8 88775387 not registered Live/Pending |
Hitting Store, LLC 2020-01-28 |
 XLR8 88396331 not registered Live/Pending |
PROSPERITY HOME MORTGAGE, LLC 2019-04-22 |
 XLR8 88185420 not registered Dead/Abandoned |
VRM International Pty Ltd 2018-11-07 |
 XLR8 88180921 not registered Live/Pending |
Price, Jacob Sidney 2018-11-04 |
 XLR8 88097915 not registered Dead/Abandoned |
GENADYNE BIOTECHNOLOGIES, INC. 2018-08-29 |
 XLR8 88080576 not registered Live/Pending |
PNY Technologies, Inc. 2018-08-16 |
 XLR8 88080570 not registered Live/Pending |
PNY Technologies, Inc. 2018-08-16 |
 XLR8 87530237 5473626 Live/Registered |
Excelerate, LLC 2017-07-17 |
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