FDA.reportPublic FDA data

Smart Laser Therapy System

Primary DI
06976812430202
Brand
Smart Laser Therapy System
Company
Rhein Laser Technologies Co.,Ltd.
Model
SMART-S60D
Published
2026-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06976812430202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976812430202069768124302026976812430202

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, home-useAn electrically-powered diode laser intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, rheumatism, disorders of the joints and soft/connective tissues), improvement of local blood/lymph circulation to facilitate healing/reduce swelling (e.g., lymphoedema therapy), or for non-needle acupuncture. It typically consists of a hand-held applicator designed for transcutaneous delivery of visible red/infrared laser light energy. It is intended to be operated by a patient/layperson in the home, typically under healthcare professional guidance.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
704587822
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976812430219TheraLight 360 Full Body WellnessTHERALIGHT 360 2026-03-06
06976812430226TheraLight 360 Full Body WellnessTHERALIGHT 10X 2026-03-06
06976812430233TheraLight 360 Full Body WellnessTHERALIGHT FIT2026-03-06
06976812430158Medical Thulium Fiber Laser SystemsUroFiber 60Q2025-01-07
06976812430127Artemis Diode Laser SystemRL-S20S-TWC2024-09-14
06976812430134Artemis Diode Laser SystemRL-S20S-810B2024-09-14
06976812430141Artemis Diode Laser SystemRL-S20S-7552024-09-14
06976812430110TitanPico Laser WorkstationPICO-4502024-09-12

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00810140063014RENPHOJoicom CorporationILY2026-05-08
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.ILY2026-05-03
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B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
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G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVE50WLS0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-10-31
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00810071230509RegenalaseIPG Medical CorporationILY2025-06-09
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