FDA.reportPublic FDA data

Lumina NRG

Primary DI
00850018806572
Brand
Lumina NRG
Company
Heatinaclick LLC
Model
6572
Device description
Mini Glow PRO
Published
2025-01-31
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
K202055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202055000Looper (Model: ZX-579S)Heat IN A Click, LLC2021-04-16OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018806572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018806572008500188065728500188065720850018806572

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, home-useAn electrically-powered, patient-worn device designed be used by a layperson in the home (may additionally be used by a healthcare professional in a clinical setting) to emit red light for phototherapy primarily to treat musculoskeletal symptoms (e.g., arthritis pain, spasm, stiffness) and increase muscle relaxation through localized modification of cellular metabolism and/or improvement of blood circulation. It is in the form of a wearable thin adhesive hydrogel patch with integrated light-emitting diodes (LEDs) designed to be applied to the affected area. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043038693
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018806541Lumina NRG65412025-01-31
00850018806602Numiere 66022025-01-31
00850018806619Lumina NRG66192025-01-31
00850018806626Lumina NRG66262025-01-31
00850018806664Numiere 66642025-01-31
00850018806701Numiere 67012025-01-31
00850018806800Fit Relief64042025-01-31
00850018806824Numiere 68242025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00622356669351Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OLP2026-05-28
18712856075024Silk'nSilkn Beauty Ltd.OLP2026-05-07
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOLP2026-04-23
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
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06977168990228NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
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00850523007365CellumaBiophotas, Inc.OLP2026-04-06
06974667829110UlikeShenzhen Ulike Smart Electronics Co., Ltd.OLP2026-03-26
07640260120600FAQ LED PanelForeo ABOLP2026-03-02
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06979826590115PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
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06979826590177PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590184PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26