PRO LH80 - Theradome PRO LH80 laser helmet is a low level - Theradome, Inc.

Duns Number:062441213

Device Description: Theradome PRO LH80 laser helmet is a low level laser therapy (LLT) device containing red, 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.

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More Product Details

Catalog Number

PRO LH80

Brand Name

PRO LH80

Version/Model Number

PRO LH80

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122950

Product Code Details

Product Code

OAP

Product Code Name

Laser, Comb, Hair

Device Record Status

Public Device Record Key

5c890697-9cb2-4f07-9356-b3b218fd9fd2

Public Version Date

December 10, 2020

Public Version Number

1

DI Record Publish Date

December 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THERADOME, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2