FDA.reportPublic FDA data

LS Pro Systems

Primary DI
00850061407085
Brand
LS Pro Systems
Company
WELLNESS WITHOUT LIMITS LLC
Model
F104
Device description
LS Pro Systems Face Pad 104 blue/red/ LED flexi-pad. Intended to emit both red and blue light for the treatment of a facial skin conditions and help with mood, circadian rhythm, sleep, and relaxation. It may also have an anti-inflammatory effect on keratinocytes, the most common cells in the outer layer of the skin. Promotes circulation at the skin level and can increase elasticity/collagen. Must be used with LS power controller.
Published
2024-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061407085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061407085008500614070858500614070850850061407085

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
020287489
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850061407122LS Pro SystemsPB-MXP1002024-06-27
00850061407139LS Pro SystemsPB-MXP1712024-06-27
00850061407207LS Pro SystemsDSD1202024-06-27
00850061407009LS Pro SystemsXP12024-05-09
00850061407016LS Pro SystemsXP32024-05-09
00850061407023LS Pro SystemsXP62024-05-09
00850061407030LS Pro SystemsG2642024-05-09
00850061407047LS Pro SystemsG264B2024-05-09
00850061407054LS Pro SystemsXL2002024-05-09
00850061407061LS Pro SystemsL1322024-05-09
00850061407078LS Pro SystemsL132B2024-05-09
00850061407092LS Pro SystemsT902024-05-09
00850061407108LS Pro SystemsH1552024-05-09
00850061407115LS Pro SystemsB1122024-05-09
00850061407153LS Pro SystemsG264-SI2024-05-09
00850061407160LS Pro SystemsXL200-SI2024-05-09
00850061407177LS Pro SystemsH155-SI2024-05-09
00850061407184LS Pro SystemsUB128-SI2024-05-09
00850061407191LS Pro SystemsLB114-SI2024-05-09
00850061407214LS Pro SystemsF122-SI2024-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
00810140063014RENPHOJoicom CorporationILY2026-05-08
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.ILY2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.ILY2026-05-02
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347BDRCKED0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347TB202400000TABLED TECHNOLOGIES INCILY2026-04-23
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
00811485037210PMDShenzhen Fittop Health Technology Co., Ltd.ILY2026-01-16
B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorBTL INDUSTRIES LIMITEDILY2025-11-19
G180DIOWAVESTEALTHLIT0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVE50WLS0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-10-31
08906172600074LightdoctorLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
08906172600081Theraray LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
00810071230509RegenalaseIPG Medical CorporationILY2025-06-09
00810071230516RegenalaseIPG Medical CorporationILY2025-06-09
00810071230530RegenalaseIPG Medical CorporationILY2025-06-09
16978368600013 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600020 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600037 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600044LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600051LED Light Therapy Mask - HIME SAMAShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600303 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600815 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05