ERCHONIA CORPORATION, LLC

Address:650 ATLANTIS RD,MELBOURNE,FL,32904,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Fat Reducing Low Level Laser (OLI) (3) Massager, Therapeutic, Electric (ISA) (2) Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy (NHN) (2)

Premarket Exempt

No Yes

Clear

Zerona 2.0 - 00858985006100 Catalog Number : GLS

Device Description : AESTHETIC - Floor Model Low Level Laser -- 6 diodes 532nm 17mW - IFU Reduction C AESTHETIC - Floor Model Low Level Laser -- 6 diodes 532nm 17mW - IFU Reduction Circumference

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : OLI

Prescription Use : Yes

Device Count : 1

Zerona AD - 00858985006117 Catalog Number : ARC

Device Description : AESTHETIC - Floor Model Low Level Laser - 6 diodes 532nm 17mW - IFU Reduction of Arms

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : OLI

Prescription Use : Yes

Device Count : 1

Zerona Z6 - 00858985006124 Catalog Number : SHR

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

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : OLI

Prescription Use : No

Device Count : 1

Adjustor - 00858985006155 Catalog Number : VA3

Device Description : THERAPEUTIC – Handheld Variable Adjuster – IFU adjunctive use for treatment of s THERAPEUTIC – Handheld Variable Adjuster – IFU adjunctive use for treatment of symptoms associate with pain

Device Class : 1

Duns Number: 004053174

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Percussor - 00858985006162 Catalog Number : VP3

Device Description : THERAPEUTIC – Handheld Galvanic Massager – IFU temporary reduction of the appear THERAPEUTIC – Handheld Galvanic Massager – IFU temporary reduction of the appearance of cellulite

Device Class : 1

Duns Number: 004053174

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

FX635 - 00858985006186 Catalog Number : HPS2

Device Description : MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Pain Reduction

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : NHN

Prescription Use : Yes

Device Count : 1

FX405 - 00858985006193 Catalog Number :

Device Description : MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - 1 diode 23mW 405 MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - 1 diode 23mW 405nm - IFU Pain Reduction, Acne Reduction

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : NHN

Prescription Use : Yes

Device Count : 1

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