Theradome, Inc.

Address:4900 Hopyard Rd Ste 100,Pleasanton,CA,94588,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

Laser, Comb, Hair (OAP) (2)

Premarket Exempt

Clear

EVO LH40 - B399EVO0400 Catalog Number : EVO LH40

Device Description : Theradome EVO LH40 laser helmet is a low level laser therapy (LLLT) devices con Theradome EVO LH40 laser helmet is a low level laser therapy (LLLT) devices containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp.

Device Class : 2

Duns Number: 062441213

Premarket Exempt : No

Product Code : OAP

Prescription Use : No

Device Count : 1

PRO LH80 - B399PRO0800 Catalog Number : PRO LH80

Device Description : Theradome PRO LH80 laser helmet is a low level laser therapy (LLT) device contai Theradome PRO LH80 laser helmet is a low level laser therapy (LLT) device containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimultion of the scalp.