Zerona Z6 SHR

GUDID 00858985006124

AESTHETIC - Floor Model Low Level Laser -- 6 diodes 635nm 17mW - OTC (Non-prescriptive) - IFU Reduction Circumference/Fat

ERCHONIA CORPORATION, LLC

Low-intensity laser fat liquefaction system

• Primary Device ID: 00858985006124
• NIH Device Record Key: 0fdbb7ce-29cb-4e1d-b827-8580f0dba934
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zerona Z6
• Version Model Number: SHR
• Catalog Number: SHR
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (888) 242-0571
• Email: info@erchonia.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858985006124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162578

FDA Product Code

• OLI: Fat Reducing Low Level Laser

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-06
• 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