ROHRER AESTHETICS, LLC

Address:105 Citation Court,Homewood,AL,35209,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 With Microbeam\Fractional Output (ONG) (1) Powered Light Based Non-Laser Surgical Instrument (ONE) (1)

Premarket Exempt

Yes

Clear

Spectrum Laser/IPL - 00860564000317 Catalog Number :

Device Class : 2

Duns Number: 083701842

Premarket Exempt : Yes

Product Code : ONE

Prescription Use : No

Device Count : 1

Phoenix CO2 - 00860564000324 Catalog Number :

Device Description : The equipmnent is used for- human tissue vaporization. coagulation in dermatolog The equipmnent is used for- human tissue vaporization. coagulation in dermatology and plasticsurgery, general surgery, gynecology, podiatry, dental and otolaryngology.

Device Class : 2

Duns Number: 083701842

Premarket Exempt : Yes

Product Code : ONG

Prescription Use : No

Device Count : 1

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