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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Light Therapy Device
LED INTELLECTUAL PROPERTIES LLC
Elipsa Black
In Commercial Distribution

  • 00850030819024 ()
1614-01

  • Blue/red/infrared phototherapy lamp
The LED Light Therapy Mask (Models: MK-04) is an over the counter device that is intended forthe use in the treatment of full-face wrinkles.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
MK-04
In Commercial Distribution

  • 00856957008022 ()


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

  • 00667259003895 ()


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

  • 00860013019402 ()


  • 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
LED light for the treatment of wrinkles
PULSADERM LLC
RB2015
In Commercial Distribution

  • 00858830007061 ()


  • Blue/red/infrared phototherapy lamp
Shani Darden Branded Facemask Blue, Red & NIR facemask
I-SMART DEVELOPMENTS LIMITED
TN2118
In Commercial Distribution

  • 05060534510517 ()
115-HGSD

  • Blue/red/infrared phototherapy lamp
MZ Skin Mask: MZ Skin LightMAX Supercharged LED Mask 2.0
I-SMART DEVELOPMENTS LIMITED
TN2025
In Commercial Distribution

  • 05060534510418 ()
140-MZ

  • Blue/red/infrared phototherapy lamp
EOS X by Deesse Pro Blue, Red, Green & NIR facemask indicated for Acne and Wrinkles.
I-SMART DEVELOPMENTS LIMITED
TN2214
In Commercial Distribution

  • 05060534510401 ()


  • Blue/red/infrared phototherapy lamp
The LUSTRE 3XPREsS Light Beauty Therapy patches (Model: PR500l) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
PR5001
In Commercial Distribution

  • 05060282690318 ()


  • Blue/red/infrared phototherapy lamp
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