EDGE SYSTEMS LLC

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Filters

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

Lamp, Infrared, Therapeutic Heating (ILY) (4) Powered Laser Surgical Instrument (GEX) (4) Apparatus, Exhaust, Surgical (FYD) (1)

Premarket Exempt

Clear

Del Sol Red Light Therapy System - 00850043007005 Catalog Number : 70393

Device Description : Red Cordless LED - US

Device Class : 2

Duns Number: 364134791

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

Del Sol Blue Light Therapy System - 00850043007012 Catalog Number : 70392

Device Description : Blue Cordless LED - US

Device Class : 2

Duns Number: 364134791

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Del Sol Red Light Therapy System - 00850043007029 Catalog Number : 70237

Device Description : Red LED Handpiece, 12V

Device Class : 2

Duns Number: 364134791

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

Del Sol Blue Light Therapy System - 00850043007036 Catalog Number : 70146

Device Description : Blue LED Handpiece, 5V

Device Class : 2

Duns Number: 364134791

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Del Sol Red Light Therapy System - 00850043007043 Catalog Number : 70238

Device Description : Red LED Handpiece with Power Supply

Device Class : 2

Duns Number: 364134791

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

Del Sol Blue Light Therapy System - 00850043007050 Catalog Number : 70207

Device Description : Blue LED Handpiece with Power Supply

Device Class : 2

Duns Number: 364134791

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

SAFE® System Surgical Smoke Evacuator - 00850043007067 Catalog Number : 10000

Device Class : 2

Duns Number: 364134791

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Del Sol Red Light Therapy System - 00850043007340 Catalog Number : 70393-01

Device Description : Del Sol Red Cordless LED Light for EU/CE only

Device Class :

Duns Number: 364134791

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

Del Sol Blue Light Therapy System - 00850043007371 Catalog Number : 70392-01

Device Description : Del Sol Blue Cordless LED Light for EU/CE only

Device Class : 2

Duns Number: 364134791

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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