DERMAL PHOTONICS CORPORATION

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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

Light Based Over The Counter Wrinkle Reduction (OHS) (1)

Premarket Exempt

Clear

NIRA Laser - 00860296000142 Catalog Number :

Device Description : The NIRA Laser is a hand-held reusable OTC non-fractional diode laser device emp The NIRA Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single micro-USB connector interface that provides two functions: battery charging and USB communication (for charging, factory programming setup and factory diagnosis of returned devices). The NIRA Laser is used for treatment of periorbital wrinkles.

Device Class : 2

Duns Number: 079208137

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

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