DDC TECHNOLOGIES, INC.

Address:311 Woods Ave,OCEANSIDE,NY,11572,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 Laser Surgical Instrument (GEX) (5)

Premarket Exempt

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Polylase - 00860002307008 Catalog Number : Polylase LP

Device Description : Dual Output Pulsed Alexandrite and Nd:YAG Laser

Device Class : 2

Duns Number: 128532707

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

AL-40 - 00860002307022 Catalog Number : AL-40

Device Description : Pulsed Alexandrite Laser

Device Class : 2

Duns Number: 128532707

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

EPY-50 - 00860002307039 Catalog Number : EPY-50

Device Description : Pulsed Nd:YAG Laser

Device Class : 2

Duns Number: 128532707

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Polylase - 00860002307046 Catalog Number : Polylase MX

Device Description : Dual Output Pulsed Alexandrite and Nd:YAG Laser

Device Class : 2

Duns Number: 128532707

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Polylase - 90860002307018 Catalog Number : Polylase AL

Device Description : Pulsed Alexandrite Laser

Device Class : 2

Duns Number: 128532707

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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