Pulsaderm RED LED Skin Renewal

GUDID 00864918000312

Red LED Light for Wrinkles

PULSADERM LLC

Red/blue light phototherapy unit
Primary Device ID00864918000312
NIH Device Record Key8e487f93-b393-4e87-80d5-d481a5ea85cf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulsaderm RED LED Skin Renewal
Version Model NumberPD5000R
Company DUNS080429881
Company NamePULSADERM LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100864918000312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OHSLight Based Over The Counter Wrinkle Reduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-05
Device Publish Date2018-10-04

Devices Manufactured by PULSADERM LLC

00858830007764 - Pulsaderm2020-08-17 Blue LED Light for the treatment of acne
00858830007023 - Instant Face Lift 2019-10-23 Handheld device intended for facial stimulation
00858830007047 - LED Blue Acne Clearing Mask 2018-11-05 Blue LED Light for the treatment of acne
00858830007061 - Orbital LED Mask 2018-11-05 LED light for the treatment of wrinkles
00858830007191 - Hair Laser Helmet2018-11-05 Laser Device for promotion of hair growth.
00864918000305 - A.C.E Blue 2018-11-05 Blue Light for the treatment of acne
00864918000312 - Pulsaderm RED LED Skin Renewal2018-11-05Red LED Light for Wrinkles
00864918000312 - Pulsaderm RED LED Skin Renewal2018-11-05 Red LED Light for Wrinkles
00864918000329 - Blue LED Acne Clearing Light2018-11-05 Blue LED Light for the treatment of mild to moderate acne

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