FDA.reportPublic FDA data

DIMED

Primary DI
06974214160819
Brand
DIMED
Company
Wuhan Dimed Laser Technology Co., Ltd.
Model
CHERYLAS-20N
Device description
CHERYLAS-20N is a Class 4 Laser products with the wavelength of 1470nm, max. output power 20W. The product code of the device is GEX, and the device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Published
2025-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

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
K211977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211977000Medical Diode Laser SystemsWuhan Dimed Laser Technology Co., Ltd.2021-10-26GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974214160819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974214160819069742141608196974214160819

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Regulatory Flags#

DUNS number
554165991
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974214160796DIMEDCHERYLAS-15N2025-10-17
06974214160802SIRONASIRONA 1002025-10-16
06974214160789REMYZFT-15FJ2025-10-14
06974214160000DimedBERYLAS-15FJ2021-03-02
06974214160017DimedBERYLAS-15FI2021-03-02
06974214160024DimedBERYLAS-15F2021-03-02
06974214160031DimedBERYLAS-15J2021-03-02
06974214160048DimedBERYLAS-15I2021-03-02
06974214160055DimedBERYLAS-10FJ2021-03-02
06974214160062DimedBERYLAS-10FI2021-03-02
06974214160079DimedBERYLAS-10F2021-03-02
06974214160086DimedBERYLAS-10J2021-03-02
06974214160093DimedBERYLAS-10I2021-03-02
06974214160109DimedCHERYLAS-30F2021-03-02
06974214160116DimedCHERYLAS-30I2021-03-02
06974214160123DimedCHERYLAS-60I2021-03-02
06974214160130DimedCHERYLAS-70I2021-03-02
06974214160147DimedCHERYLAS-30J2021-03-02
06974214160154DimedCHERYLAS-60J2021-03-02
06974214160161DimedCHERYLAS-70J2021-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800291820200DermaVCynosure Lutronic Technology CorporationGEX2026-06-23
08800291820040CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820057CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820187CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820460HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820477HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820484HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820859PICOPLUSCynosure Lutronic Technology CorporationGEX2026-06-22
06973511890177SANOBeijing Sano Lasers S&T Development Co., Ltd.GEX2026-06-10
008164690216981150-500LASER PERIPHERALS, LLCGEX2026-06-08
G866ELITELT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
B17731260532L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2025-07-23
B17731260532Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2025-07-23
B17731260455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2025-07-21
B17731260455Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2025-07-21
00647529004722Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
00647529004777Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16