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510(k) Data Aggregation
K Number
K171775Device Name
Theradome LH80 PRO
Manufacturer
Theradome Inc.
Date Cleared
2018-01-09
(209 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Theradome Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Theradome LH80 PRO is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV.
Device Description
The Theradome LH80 PRO for men and women is a low level coherent light therapy (LLLT) device utilised to promote hair growth. The coherent lights are contained inside a lightweight, one-size fits all helmet. The Theradome LH80 PRO uses 80 coherent light diodes in the helmet to deliver coherent light stimulation to the entire scalp for hands-free operation during treatment. An audible timer automatically turns the coherent lights off after the 20 minutes treatment is completed. This coherent light helmet is not constructed to be a safety helmet.
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K Number
K122950Device Name
LASER HELMET
Manufacturer
THERADOME INC.
Date Cleared
2013-06-14
(262 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
THERADOME INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Theradome Laser Helmet LH80 PRO is an over the counter (OTC)device indicated to treat androgenic alopecia, to Promote hair growth in females with female pattern hair loss (FPHL) on the Ludwig and Savin Hair Loss Scale I-II, Fitzpatrick Skin-Types I to IV:
Device Description
The Theradome Laser Helmet LH80 PRO is a low level laser therapy (LLLT) device used to promote hair growth via photobiostimulation. The lasers are contained inside a lightweight, one-size fits all helmet. The LH80 PRO utilizes 80 laser diodes in the helmet to deliver laser stimulation to the entire scalp for hands-free operation during treatment. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the 20 minute treatment completes.
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K Number
K113097Device Name
LASER HELMET
Manufacturer
THERADOME INC.
Date Cleared
2012-03-02
(135 days)
Product Code
OAP, NHN, REQ
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
THERADOME INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Theradome Laser Helmet LH80 PRO is intended to treat androgenic alopecia by promoting hair growth.
The Theradome Laser Helmet LH80 PRO is a prescription use therapeutic device indicated to promote hair growth in females, with androgenic alopedia, having Ludwig and Savin Hair Loss Scale classification I-II and Fitzpatrick Skin-Types I to IV.
Device Description
The Theradome Laser Helmet LH80 PRO is a low level laser therapy (LLT) device used to promote hair growth via photobiostimulation. The lasers are contained inside a lightweight, one-size fits all helmet. The LH80 PRO utilizes laser diodes in the heimet to deliver laser stimulation to the entire scalp for hands-free operation during treatment. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the 20 minute treatment completes.
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