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

Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy (NHN) (7) Fat Reducing Low Level Laser (OLI) (2) Powered Laser Surgical Instrument (GEX) (2) Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (PDZ) (1)

Premarket Exempt

No Yes

Clear

Base Station - 00858985006001 Catalog Number : BST

Device Description : MEDICAL - Desk Top Model Docking Station - includes 2 XLR8 & 1 EVRL low level la MEDICAL - Desk Top Model Docking Station - includes 2 XLR8 & 1 EVRL low level laser devices

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : GEX, NHN

Prescription Use : Yes

Device Count : 1

Emerald - 00858985006018 Catalog Number : SHL

Device Description : AESTHETIC - Floor Model Low Level Laser -- 10 diodes 532nm 17mW - IFU Reduction AESTHETIC - Floor Model Low Level Laser -- 10 diodes 532nm 17mW - IFU Reduction BMI +30 or greater

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : OLI

Prescription Use : Yes

Device Count : 1

EVL - 00858985006025 Catalog Number : EVL

Device Description : VETERINARY - Handheld Low Level Laser - 2 diodes 640nm & 405 nm 7.5 mW - include VETERINARY - Handheld Low Level Laser - 2 diodes 640nm & 405 nm 7.5 mW - includes induction charger

Device Class : 2

Duns Number: 004053174

Premarket Exempt : Yes

Product Code : NHN

Prescription Use : No

Device Count : 1

EVRL - 00858985006032 Catalog Number : EVRL

Device Description : MEDICAL - Handheld Low Level Laser - 2 diodes 640nm & 405 nm 7.5 mW - includes i MEDICAL - Handheld Low Level Laser - 2 diodes 640nm & 405 nm 7.5 mW - includes induction charger - IFU Reduction Pain, Reduction Acne

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : GEX, NHN

Prescription Use : Yes

Device Count : 1

FX635 - 00858985006049 Catalog Number : HPS

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

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : NHN

Prescription Use : Yes

Device Count : 1

Lunula - 00858985006056 Catalog Number : FFS

Device Description : MEDICAL - Floor Model Low Level Laser - 2 diodes 635nm & 405nm - IFU Reduction O MEDICAL - Floor Model Low Level Laser - 2 diodes 635nm & 405nm - IFU Reduction Onychomycosis

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : PDZ

Prescription Use : Yes

Device Count : 1

PL Touch - 00858985006063 Catalog Number : PLT

Device Description : MEDICAL - Handheld Low Level Laser - 2 diodes 635nm 7mW - IFU Reduction Pain

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : NHN

Prescription Use : Yes

Device Count : 1

Verju - 00858985006070 Catalog Number : CLS

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

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : OLI

Prescription Use : Yes

Device Count : 1

VLS - 00858985006087 Catalog Number : VLS

Device Description : VETERINARY - Handheld Low Level Laser - 2 diodes 640nm 10mW - includes induction charger

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : NHN

Prescription Use : Yes

Device Count : 1

XLR8 - 00858985006094 Catalog Number : HLS

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

Device Class : 2

Duns Number: 004053174

Premarket Exempt : No

Product Code : NHN

Prescription Use : Yes

Device Count : 1

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