Artemis Diode Laser System

Primary DI
06976812430127
Brand
Artemis Diode Laser System
Company
Rhein Laser Technologies Co.,Ltd.
Model
RL-S20S-TWC
Published
2024-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233756000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233756000Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)Rhein Laser Technologies Co., Ltd.2024-02-02GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976812430127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976812430127069768124301276976812430127

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam designed to perform dermatological procedures such as body hair removal (e.g., armpit, leg/arm, back, chest, bikini line, and face) and/or skin resurfacing (e.g., treatment of benign lesions, wrinkle reduction). It is intended to be used by a trained professional to emit pulsed light of a specific wavelength (e.g., around 808 nm or 1060 nm), delivered by a dedicated handpiece. It typically includes a control unit with dedicated software and user interface, delivery handpiece, and footswitch.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
704587822
Device count
1
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
06976812430202Smart Laser Therapy SystemSMART-S60D2026-01-19
06976812430158Medical Thulium Fiber Laser SystemsUroFiber 60Q2025-01-07
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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08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16