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 Size Type Device Class Implantable

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Over the counter red/IR device for the treatment of wrinkles.
Omm Imports Inc.
PX100
In Commercial Distribution

  • 00850001456036 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red and infrared phototherapy device for the treatment of wrinkles.
Omm Imports Inc.
P900B
In Commercial Distribution

  • 00850001456012 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red and infrared phototherapy device for the treatment of wrinkles.
Omm Imports Inc.
P850B
In Commercial Distribution

  • 00850001456005 ()


  • Blue/red/infrared phototherapy lamp
LED infrared light therapy wrap for amputees
PHYSIOHAB LLC
OLKA3003
In Commercial Distribution

  • 00860013229085 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared therapy wrap for the elbow
PHYSIOHAB LLC
OLE3006
In Commercial Distribution

  • 00860013229078 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared therapy device for the foot
PHYSIOHAB LLC
OLF3009
In Commercial Distribution

  • 00860013229061 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared light therapy wrap for the ankle
PHYSIOHAB LLC
OLA3001
In Commercial Distribution

  • 00860013229054 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared light therapy wrap for the Knee
PHYSIOHAB LLC
OLK3002
In Commercial Distribution

  • 00860013229047 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared therapy device for the Neck
PHYSIOHAB LLC
OLN3004
In Commercial Distribution

  • 00860013229030 ()


  • Blue/red/infrared phototherapy lamp
ONLUX Shoulder LED Infrared therapy device
PHYSIOHAB LLC
OLS3005
In Commercial Distribution

  • 00860013229023 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared Therapy device for the hand
PHYSIOHAB LLC
OLH3007
In Commercial Distribution

  • 00860013229016 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared therapy device for the lumbar
PHYSIOHAB LLC
OLL3003
In Commercial Distribution

  • 00860013229009 ()


  • Blue/red/infrared phototherapy lamp
No Description
Elixir M.D. Inc.
LED Light Therapy Device
In Commercial Distribution

  • 00860013019402 ()


  • Blue/red/infrared phototherapy lamp
No Description
Lumebox LLC
LB-001A
In Commercial Distribution

  • 00860008109217 ()


  • Blue/red/infrared phototherapy lamp
No Description
Silhouet-Tone Corporation
411569
In Commercial Distribution

  • 00667259003895 ()


  • Blue/red/infrared phototherapy lamp
No Description
Rst- Sanexas
55105
In Commercial Distribution

  • 00860000214056 ()


  • Blue/red/infrared phototherapy lamp
No Description
Rst- Sanexas
55105
In Commercial Distribution

  • 00860000214025 ()
  • 10860000214022 ()


  • Blue/red/infrared phototherapy lamp
LED light for the treatment of wrinkles
PULSADERM LLC
RB2015
In Commercial Distribution

  • 00858830007061 ()


  • Blue/red/infrared phototherapy lamp
No Description
HILL LABORATORIES CO.
Electro Light Therapy
In Commercial Distribution

  • 00860001452549 ()


  • Blue/red/infrared phototherapy lamp
No Description
BIOPHOTAS, INC.
Lite C/US
In Commercial Distribution

  • 00850523007204 ()


  • Blue/red/infrared phototherapy lamp
3 mode small panel
BIOPHOTAS, INC.
iLITE C/US
In Commercial Distribution

  • 00850523007181 ()
CLTB-001

  • Blue/red/infrared phototherapy lamp
3 mode full body panel
BIOPHOTAS, INC.
DELUX XL C/US
In Commercial Distribution

  • 00850523007143 ()
CDLX-003

  • Blue/red/infrared phototherapy lamp
3 mode full body panel
BIOPHOTAS, INC.
DELUX C/US
In Commercial Distribution

  • 00850523007129 ()
CDLX-001

  • Blue/red/infrared phototherapy lamp
1-mode small panel
BIOPHOTAS, INC.
CLEAR C/US
In Commercial Distribution

  • 00850523007037 ()
CLTC-001

  • Blue/red/infrared phototherapy lamp
The Joovv Go 2.0 is a handheld phototherapy device that emits light in the Red and Near Infrared spectrum.
JOOVV, INC.
PT500-F0488
In Commercial Distribution

  • 00855501008280 ()


  • Blue/red/infrared phototherapy lamp
The Joovv Mini 3.0 is a portable phototherapy device that emits light in the Red and Near Infrared spectrum.
JOOVV, INC.
PT500-F0487
In Commercial Distribution

  • 00855501008273 ()


  • Blue/red/infrared phototherapy lamp
The Joovv Solo 3.0 is a portable phototherapy device that emits light in the Red and Near Infrared spectrum.
JOOVV, INC.
PT500-F0486
In Commercial Distribution

  • 10855501008263 ()
  • 00855501008266 ()


  • Blue/red/infrared phototherapy lamp
The Joovv Go Red is a rechargeable, battery powered LED therapeutic heating device for pain relief.
JOOVV, INC.
EA-012660000
Not in Commercial Distribution

  • 10855501008218 ()
  • 00855501008211 ()


  • Blue/red/infrared phototherapy lamp
A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.
UPLEVITY LLC
LYFT3
In Commercial Distribution

  • 00855950007049 ()


  • Blue/red/infrared phototherapy lamp
Light Therapy Device
LED INTELLECTUAL PROPERTIES LLC
Elipsa Black
In Commercial Distribution

  • 00850030819024 ()
1614-01

  • Blue/red/infrared phototherapy lamp
No Description
CONAIR CORPORATION
MASK4
In Commercial Distribution

  • 00074108504753 ()
  • 10074108504750 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
LUXGLO
In Commercial Distribution

  • B347LUXGLO1 ()
  • B347LUXGLO0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
LTSRCE
In Commercial Distribution

  • B347LTSRCE1 ()
  • B347LTSRCE0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
LR100
Not in Commercial Distribution

  • B347LR1001 ()
  • B347LR1000 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HSNCKPW
Not in Commercial Distribution

  • B347HSNCKPW1 ()
  • B347HSNCKPW0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HSKNEE
Not in Commercial Distribution

  • B347HSKNEE1 ()
  • B347HSKNEE0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HSFLXWW
Not in Commercial Distribution

  • B347HSFLXWW1 ()
  • B347HSFLXWW0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HSFLXPD
Not in Commercial Distribution

  • B347HSFLXPD1 ()
  • B347HSFLXPD0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HSFLXMT
Not in Commercial Distribution

  • B347HSFLXMT1 ()
  • B347HSFLXMT0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HSANKLE
Not in Commercial Distribution

  • B347HSANKLE1 ()
  • B347HSANKLE0 ()


  • Blue/red/infrared phototherapy lamp
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