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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Collagentex Rx-3 NIR device, model Rx-3, 3 lamp module
Tanses Technologies Inc
Rx-3
In Commercial Distribution

  • 00850056256438 ()


  • Red-light phototherapy unit, professional
Collagentex Rx-2 NIR device, model Rx-2, 2 lamp module
Tanses Technologies Inc
Rx-2
In Commercial Distribution

  • 00850056256421 ()


  • Red-light phototherapy unit, professional
Collagentex Rx-1-Seat NIR device, Seat version, model Rx-1-Seat, 1 lamp module
Tanses Technologies Inc
RX-1-Seat
In Commercial Distribution

  • 00850056256414 ()


  • Red-light phototherapy unit, professional
180 Tricolor Blue/IR/Red LED Pad, Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-180T
In Commercial Distribution

  • 00858935006556 ()
502041

  • Musculoskeletal infrared phototherapy unit, non-wearable
132 Blue/IR LED Pad, Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-132B
In Commercial Distribution

  • 00858935006549 ()
502040

  • Musculoskeletal infrared phototherapy unit, non-wearable
264 Blue/IR LED Pad, Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-264B
In Commercial Distribution

  • 00858935006532 ()
502037

  • Musculoskeletal infrared phototherapy unit, non-wearable
HealthLight 180 & 264 LED Combo Pad System - Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-444-S
In Commercial Distribution

  • 00858935006525 ()
502036

  • Musculoskeletal infrared phototherapy unit, non-wearable
132-LED Blue/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-132B
In Commercial Distribution

  • 00858935006518 ()
602024

  • Musculoskeletal infrared phototherapy unit, non-wearable
Three Port CAREController - Phototherapy Control Device for up to 3 separate phototherapy emitters
HEALTHLIGHT LLC
CL-C3
In Commercial Distribution

  • 00858935006501 ()
602023, 602030

  • Musculoskeletal infrared phototherapy unit, non-wearable
180-LED Tricolor Blue/IR/Red CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-180T
In Commercial Distribution

  • 00858935006495 ()
602022

  • Musculoskeletal infrared phototherapy unit, non-wearable
264-LED Blue/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-264B
In Commercial Distribution

  • 00858935006488 ()
602021

  • Musculoskeletal infrared phototherapy unit, non-wearable
Face Mask CAREPad - Phototherapy Device
HEALTHLIGHT LLC
CL-FM
In Commercial Distribution

  • 00858935006471 ()
602020

  • Musculoskeletal infrared phototherapy unit, non-wearable
Foot & Ankle Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-PB
In Commercial Distribution

  • 00858935006464 ()
602019

  • Musculoskeletal infrared phototherapy unit, non-wearable
64-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-64R
In Commercial Distribution

  • 00858935006457 ()
602018

  • Musculoskeletal infrared phototherapy unit, non-wearable
Two Port CAREController - Infrared Phototherapy control device for up to 2 phototherapy emitters
HEALTHLIGHT LLC
CL-C2
In Commercial Distribution

  • 00858935006440 ()
602017

  • Musculoskeletal infrared phototherapy unit, non-wearable
Six Port CAREController - Phototherapy Control Device for up to 6 separate phototherapy emitters
HEALTHLIGHT LLC
CL-C6
In Commercial Distribution

  • 00858935006433 ()
602016, 602025, 602031

  • Musculoskeletal infrared phototherapy unit, non-wearable
Foot & Calf Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-NP
In Commercial Distribution

  • 00858935006426 ()
602015

  • Musculoskeletal infrared phototherapy unit, non-wearable
264-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-264R
In Commercial Distribution

  • 00858935006419 ()
602014

  • Musculoskeletal infrared phototherapy unit, non-wearable
180-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-180R
In Commercial Distribution

  • 00858935006402 ()
602013

  • Musculoskeletal infrared phototherapy unit, non-wearable
132-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-132R
In Commercial Distribution

  • 00858935006396 ()
602012

  • Musculoskeletal infrared phototherapy unit, non-wearable
90-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-90R
In Commercial Distribution

  • 00858935006389 ()
602011

  • Musculoskeletal infrared phototherapy unit, non-wearable
Lumen MD Foot and Hand Pad System
HEALTHLIGHT LLC
LM-CP-S
In Commercial Distribution

  • 00858935006372 ()
602009

  • Musculoskeletal infrared phototherapy unit, non-wearable
Healthlight Foot and Hand Pad System
HEALTHLIGHT LLC
HL-CP-S
In Commercial Distribution

  • 00858935006365 ()
502035

  • Musculoskeletal infrared phototherapy unit, non-wearable
Lumen MD Dual Foot and Ankle System
HEALTHLIGHT LLC
LM-NP2-S
In Commercial Distribution

  • 00858935006358 ()
602008

  • Musculoskeletal infrared phototherapy unit, non-wearable
Lumen MD Foot and Ankle Pad System
HEALTHLIGHT LLC
LM-NP-S
In Commercial Distribution

  • 00858935006341 ()
602007

  • Musculoskeletal infrared phototherapy unit, non-wearable
Dual Foot And Calf Pad System
HEALTHLIGHT LLC
HL-NP2-S
In Commercial Distribution

  • 00858935006280 ()
502034

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
120-2
In Commercial Distribution

  • 00859101006097 ()
498011

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
480 Recertified
In Commercial Distribution

  • 00859101006042 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
480
In Commercial Distribution

  • 00859101006035 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
120 Professional
In Commercial Distribution

  • 00859101006028 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
120 Recertified
In Commercial Distribution

  • 00859101006011 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
120
In Commercial Distribution

  • 00859101006004 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Silhouet-Tone Corporation
411560
In Commercial Distribution

  • 00667259001952 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
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
The Joovv Solo is a red/infrared LED heating device for therapeutic pain relief.
JOOVV, INC.
EA-150660850
Not in Commercial Distribution

  • 10855501008010 ()
  • 00855501008013 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The Joovv Mini is a red/infrared LED heating device for therapeutic pain relief.
JOOVV, INC.
EA-060660850
Not in Commercial Distribution

  • 00855501008006 ()
  • 10855501008003 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
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 NIR is a rechargeable, battery powered infrared LED heating device for therapeutic pain relief.
JOOVV, INC.
EA-012850000
Not in Commercial Distribution

  • 10855501008225 ()
  • 00855501008228 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
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