FDA.reportPublic FDA data

Luminance RED Acne Device

Primary DI
00860002593036
Brand
Luminance RED Acne Device
Company
Luminance Medical Ventures Incorporated
Model
TN1927D
Published
2023-05-24
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
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220729000The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.2022-06-09OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002593036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002593036008600025930368600025930360860002593036

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
065554288
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850063220064Luminance RED Cold Sore DeviceTN1927G2026-01-27
00860009581784The Luminance RED - Genital Sore PRO DeviceTN1927F2025-04-04
00860002593005Luminance RED Lip DeviceTN1927A2023-05-26
00860002593043Luminance RED Mouth DeviceTN1927B2023-05-26
00860002593050Luminance RED Genital DeviceTN1927C2023-05-26
00860002593074Luminance RED TipBE-NQUQ-FSF82023-05-26

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