FDA.reportPublic FDA data

DIMED

Primary DI
06974214160796
Brand
DIMED
Company
Wuhan Dimed Laser Technology Co., Ltd.
Model
CHERYLAS-15N
Device description
CHERYLAS-15N is a Class 4 Laser products with the wavelength of 1470nm, max. output power 15W. 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
06974214160796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974214160796069742141607966974214160796

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
06974214160819DIMEDCHERYLAS-20N2025-10-17
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
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16