Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Class Implantable

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iGrow Hair Growth System, Standard Single Unit
APIRA SCIENCE, INC.
PE104IG00
In Commercial Distribution

  • 20861134000106 ()
  • 00861134000102 ()
  • 10861134000109 ()


  • Hair growth laser device
The iRestore Elite is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I-IV.
Remax Medi-Tech (Shenzhen) Corporation
ID-510
In Commercial Distribution

  • 10859690003917 ()
  • 00859690003910 ()


  • Hair growth laser device
iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood Hamilton Classifications of Ila to V and in females who have Ludgwig-Savin Classifications of I to II . All users should also have Fitzpatrick Skin Types I to IV. The iRestore Hair Growth System uses 51 low-level lasers and 69 light-emitting diodes .
Remax Medi-Tech (Shenzhen) Corporation
ID-500
In Commercial Distribution

  • 00859690003897 ()
  • 10859690003894 ()


  • Hair growth laser device
The iRestore Professional 282 is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V and in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II, and in both with Fitzpatrick Skin Phototypes I-IV.
FREEDOM LASER THERAPY, INC.
ID-505
In Commercial Distribution

  • 10859690003672 ()
  • 00859690003675 ()


  • Hair growth laser device
The iRestore Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV. The iRestore Hair Growth System uses 21 low-level lasers and 30 light emitting diodes (LED).
Remax Medi-Tech (Shenzhen) Corporation
ID-500
In Commercial Distribution

  • 00859690003361 ()
  • 10859690003368 ()


  • Hair growth laser device
Low level laser therapy device.
WONTECH CO.,LTD
Hair Boom69, Hair Beam Air, Hair Boom, Hair Boom Air, Ulike Hair UpUp
In Commercial Distribution

  • 08800022304924 ()


  • Hair growth laser device
Low level laser therapy device.
WONTECH CO.,LTD
Hair Boom69, Hair Boom
In Commercial Distribution

  • 08800022304917 ()


  • Hair growth laser device
Low level laser therapy device
WONTECH CO.,LTD
Hair Boom
In Commercial Distribution

  • 08800022300674 ()


  • Hair growth laser device
Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 280 laser diodes. The Cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included battery pack.
Shang Far Biotechnology Co.
TW280
In Commercial Distribution

  • 04719892822800 ()


  • Hair growth laser device
Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 147 laser diodes. The Cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included battery pack.
Shang Far Biotechnology Co.
TW147
In Commercial Distribution

  • 04719892821476 ()


  • Hair growth laser device
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