PHOTONMD, INC.

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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

Laser, Comb, Hair (OAP) (1)

Premarket Exempt

Clear

REVIAN RED - 00862712000309 Catalog Number : 10001

Device Description : REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated via a mobile application to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment.REVIAN RED is a system comprised of a wearable soft textile Cap using driver electronics,a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board. REVIAN RED is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled via a wireless Bluetooth connection to a mobile application operating on a wireless device.

Device Class : 2

Duns Number: 080259941

Premarket Exempt : No

Product Code : OAP

Prescription Use : No

Device Count : 1

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