FDA.reportPublic FDA data

Nd:Yag Laser Therapy Systems

Primary DI
06973663790042
Brand
Nd:Yag Laser Therapy Systems
Company
BEIJING UNT TECHNOLOGY CO.,LTD
Model
Nd:Yag Pro X
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

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
K232532000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232532000Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.2023-11-02GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973663790042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973663790042069736637900426973663790042

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state/carbon dioxide laser systemA mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one solid-state [e.g., neodymium-doped yttrium-aluminium-garnet (Nd:YAG)] mediated and the other carbon dixoide (CO2) mediated, intended for bloodless incisions during general surgery and/or multiple specialized surgical applications (non-dedicated). It is intended to provide both the cutting capabilities of gas mediated lasing, and the haemostatic abilities of solid-state mediated lasing. It includes a light source, delivery/positioning device(s), and controls/foot-switch. It does not include frequency doubling technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
414096217
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973663791049Diode Laser Therapy SystemsAlpha2024-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
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EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
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00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
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08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
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08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
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