FDA.reportPublic FDA data

CO2 Laser System

Primary DI
06978716980036
Brand
CO2 Laser System
Company
Sanhe Meditech Co.Ltd
Model
GL066
Published
2026-05-13
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
K260257000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260257000CO2 Laser SystemSanhe Meditech Co., Ltd.2026-03-28GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06978716980036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978716980036069787169800366978716980036

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode/carbon dioxide laser systemA mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one diode mediated, and the other carbon dixoide (CO2) mediated, intended for aesthetic and tissue reconstructive applications across multiple clinical specialties (e.g., dermatological, gynaecological, urological applications) using both ablative and non-ablative lasing. It includes a laser generator with controls and a monitor.

Regulatory Flags#

DUNS number
443657496
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978716980012Diode Laser Hair Removal MachineGLD012026-05-13
06978716980029Nd: YAG Laser Therapy SystemsGL0222026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
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08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
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08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
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08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16