FDA.reportPublic FDA data

InPulse Dental Laser

Primary DI
00857848007674
Brand
InPulse Dental Laser
Company
Beyond International Inc.
Model
InPulse Touch 100
Published
2022-12-23
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857848007674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857848007674008578480076748578480076740857848007674

GMDN Terms#

Term, Definition table
TermDefinition
Dental solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater.

Regulatory Flags#

DUNS number
080721790
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857848007094GeminiBY-GM2242023-05-08
00857848007124BEYOND® Polus® Advanced Whitening AcceleratorPLS-868A 2022-12-23
00857848007131BEYOND® II Whitening AcceleratorBE-8182022-12-23
00857848007209BEYOND® BlueSeal® Gingival Protection (5 pack) BY-PD022052022-12-23
00857848007216BEYOND® FlexiBlue® Comfort Cheek Retractors (5 pack)BY-PD01205M2022-12-23
00857848007223BEYOND® FlexiBlue® Comfort Cheek Retractors (5 pack)BY-PD01205L2022-12-23
00857848007292BEYOND® II Cheek Retractor (5 pack)BY-M0122022-12-23
00857848007315BEYOND® BlueSeal® Gingival Protection Twin PackBY-PD022022022-12-23
00857848007599BEYOND® FlexiPro™ Cheek Retractor (5 pack)-LBY-M015-L2022-12-23
00857848007605BEYOND® FlexiPro™ Cheek Retractor (single pack)-LBY-M016-L2022-12-23
00857848007681BEYOND® FlexiPro™ Cheek Retractor (5 pack)-MBY-M015-M2022-12-23
00857848007698BEYOND® FlexiPro™ Cheek Retractor (single pack)-MBY-M016-M2022-12-23
00857848007704BEYOND® FlexiPro™ Cheek Retractor (5 pack)-MixedBY-M015-MIX2022-12-23
00857848007711BEYOND® Polus® Advanced Ultra Whitening AcceleratorPLS-868UL2022-12-23
00857848007728BEYOND® II Ultra Whitening AcceleratorBE-818UL2022-12-23

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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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00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
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06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
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