FDA.reportPublic FDA data

Pulsaderm RED LED Skin Renewal

Primary DI
00864918000312
Brand
Pulsaderm RED LED Skin Renewal
Company
PULSADERM LLC
Model
PD5000R
Device description
Red LED Light for Wrinkles
Published
2018-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141308000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141308000NUTRA LIGHT REDNutra Luxe MD, LLC2014-08-20OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864918000312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864918000312008649180003128649180003120864918000312

GMDN Terms#

Term, Definition table
TermDefinition
Red/blue light phototherapy unitA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080429881
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858830007023Instant Face Lift RB200002018-10-04
00858830007764PulsadermPD9700R2020-08-07
00858830007061Orbital LED Mask RB20152018-10-04
00858830007191Hair Laser HelmetRB20402018-10-04
00864918000343NutraStim Hair Laser CombPD8021NS2018-10-03
00864918000374L.E.D Light Therapy Mask (Red) RB20102018-10-04
00858830007047LED Blue Acne Clearing Mask PD97002018-10-04
00864918000305A.C.E Blue PD95052018-10-04
00864918000329 Blue LED Acne Clearing LightPD5000B2018-10-04
00864918000336A.C.E Red and Blue PD9500 2018-10-04

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