Luminance RED Genital Device

GUDID 00860002593050

Luminance Medical Ventures Incorporated

Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use
Primary Device ID00860002593050
NIH Device Record Key76f16164-bff5-423f-9d96-b3e171c902b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLuminance RED Genital Device
Version Model NumberTN1927C
Company DUNS065554288
Company NameLuminance Medical Ventures Incorporated
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002593050 [Primary]

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-05
Device Publish Date2023-05-26

Devices Manufactured by Luminance Medical Ventures Incorporated

00860002593005 - Luminance RED Lip Device2023-06-05
00860002593043 - Luminance RED Mouth Device2023-06-05
00860002593050 - Luminance RED Genital Device2023-06-05
00860002593050 - Luminance RED Genital Device2023-06-05
00860002593074 - Luminance RED Tip2023-06-05
00860002593036 - Luminance RED Acne Device2023-06-01

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