Clinicon Corporation

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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

Powered Laser Surgical Instrument (GEX) (10)

Premarket Exempt

Clear

SureTouch - 00850013050116 Catalog Number :

Device Description : SureTouch, 1.5mm Universal HandPiece (UHP)

Device Class : 2

Duns Number: 785275777

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SureTip - 00850013050123 Catalog Number :

Device Description : SureTip, GEN, 10mm, straight tip

Device Class : 2

Duns Number: 785275777

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SureBlade - 00850013050130 Catalog Number :

Device Description : SureBlade 6mm, Lance, double edged, (No. 13)

Device Class : 2

Duns Number: 785275777

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SureBlade - 00850013050147 Catalog Number :

Device Description : SureBlade 8mm, BiFacet, single edged, (No.11)

Device Class : 2

Duns Number: 785275777

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SureGuide - 00850013050154 Catalog Number :

Device Description : SureGuide, 2.00m Fiber Cable Assembly, SMA Connector with Interlock Wire

Device Class : 2

Duns Number: 785275777

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SureGuide - 00850013050161 Catalog Number :

Device Description : SureGuide, 2.00m Fiber Cable Assembly, ST Connector

Device Class : 2

Duns Number: 785275777

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SureGuide - 00850013050178 Catalog Number :

Device Description : SureGuide, 2.75m Fiber Cable Assembly,SMA with Interlock Wire

Device Class : 2

Duns Number: 785275777

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SureGuide - 00850013050185 Catalog Number :

Device Description : SureGuide, 2.75m Fiber Cable Assembly, ST Connector

Device Class : 2

Duns Number: 785275777

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SureScan - 00850013050192 Catalog Number :

Device Description : SureScan, Fractional Laser Scanner

Device Class : 2

Duns Number: 785275777

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Luxar - 00850013050208 Catalog Number :

Device Description : Luxar "NovaPulse" 30 Watt Laser System, refurbished, 2-Year Warranty

Device Class : 2

Duns Number: 785275777

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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