FOCUS MEDICAL, LLC

Address:23 FRANCIS J. CLARKE CIRCLE,Bethel,CT,06801,US

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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) (3) Dressing, Wound, Hydrogel Without Drug And/Or Biologic (NAE) (1) Powered Laser Surgical Instrument With Microbeam\Fractional Output (ONG) (1)

Premarket Exempt

No Yes

Clear

Focus Medical - 00865601000312 Catalog Number :

Device Class : 2

Duns Number: 841432912

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Carbon Wave Patch - 00865601000329 Catalog Number :

Device Class : 1

Duns Number: 841432912

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Focus Medical - 00865601000336 Catalog Number :

Device Class : 2

Duns Number: 841432912

Premarket Exempt : No

Product Code : ONG

Prescription Use : No

Device Count : 1

Focus Medical - 00865601000343 Catalog Number :

Device Class : 2

Duns Number: 841432912

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Focus Medical - 00865601000350 Catalog Number :

Device Class : 2

Duns Number: 841432912

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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