RAJA Medical

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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

Brush, Dermabrasion, Powered (GFE) (1) Powered Laser Surgical Instrument (GEX) (1)

Premarket Exempt

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OXYLIGHT - G050OXYLIGHT0 Catalog Number :

Device Description : The OxyLight system is a skin care therapy system that that uses multiple therap The OxyLight system is a skin care therapy system that that uses multiple therapeutic modalities delivered through different attachments or handles. The system includes a panel that irradiates Blue, Red and Yellow LED light for photodynamic therapy and Oxygen spray therapy as well as a microdermabrasion handle.

Device Class : 1

Duns Number: 780355074

Premarket Exempt : No

Product Code : GEX, GFE

Prescription Use : Yes

Device Count : 1

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