Acclaro 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) (4)

Premarket Exempt

Clear

UltraClear - 00850039149016 Catalog Number :

Device Description : Fractional Mid IR Fiber Laser System (White)

Device Class : 2

Duns Number: 105941754

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

UltraClear - 00850039149023 Catalog Number :

Device Description : Fractional Mid IR Fiber Laser System (Black)

Device Class : 2

Duns Number: 105941754

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

UltraClear - 00850039149030 Catalog Number :

Device Description : Fractional Mid IR Fiber Laser System (Purple Metallic)

Device Class : 2

Duns Number: 105941754

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

UltraClear - 00850039149047 Catalog Number :

Device Description : Fractional Mid IR Fiber Laser System (Blue Metallic)

Device Class : 2

Duns Number: 105941754

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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